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This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.
The primary objectives of this study are to compare the immune response of Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children with cancer and in children with HIV.
The secondary objectives of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leukemia-HD | Active Comparator | Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses. |
|
| Leukemia-SD | Active Comparator | Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses. |
|
| Solid Tumor-HD | Active Comparator | Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses. |
|
| Solid Tumor-SD | Active Comparator | Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses. |
|
| HIV-HD | Active Comparator | Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone High Dose Vaccine | Biological | Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Seroconversion After 1 Dose of Vaccine | The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10. | at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose |
| Rate of Seroprotection After 1 Dose of Vaccine | The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40. | at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose |
| Number of Participants Achieving Seroprotection After Second Dose of Vaccine | The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40. | 21 to 42 days after second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD | Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD. | From initial vaccine administration through up to 8 months |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan A McCullers, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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Participants excluded if they had: pre-vaccination titer of ≥1:2560, severe hypersensitivity to egg proteins or any component of Fluzone, life-threatening reaction after prior influenza vaccine, history of Guillain-Barre syndrome in subject/subject's family, or unwilling to agree to acceptable birth control for 3 months after each dose.
Participants were ≥3-21 yrs. at study entry with diagnosis of cancer or HIV. Those with cancer were receiving chemotherapy and/or radiotherapy or had received chemotherapy in the prior 12 weeks. One participant was enrolled but was lost to follow up prior to randomization. 84 participants were randomized between 9/2010 and 10/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Leukemia-HD | Patients with a diagnosis of leukemia who received the high dose Fluzone HD. |
| FG001 | Leukemia-SD | Patients with a diagnosis of leukemia who received the standard dose Fluzone. |
| FG002 | Solid Tumor-HD | Patients with a diagnosis of solid tumor who received the high dose Fluzone HD. |
| FG003 | Solid Tumor-SD | Patients with a diagnosis of solid tumor who received the standard dose Fluzone. |
| FG004 | HIV-HD | Patients with a diagnosis of HIV who received the high dose Fluzone HD. |
| FG005 | HIV-SD | Patients with a diagnosis of HIV who received the standard dose Fluzone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This was an open-label study where participants were randomized at a 1:1 ratio into Fluzone high-dose (HD) and Fluzone standard dose (SD) groups by disease group with the use of a computer-generated randomization schedule.
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| ID | Title | Description |
|---|---|---|
| BG000 | Leukemia-HD | Patients with a diagnosis of leukemia who received the high dose Fluzone HD. |
| BG001 | Leukemia-SD | Patients with a diagnosis of leukemia who received the standard dose Fluzone. |
| 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 | Rate of Seroconversion After 1 Dose of Vaccine | The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10. | Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response. | Posted | Number | percentage of participants | at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose |
|
Adverse events were collected for 21 days after each dose of vaccine. No "other" adverse events were observed.
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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 | Leukemia-HD | Patients with a diagnosis of leukemia who received the high dose Fluzone HD. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | CTCAE (4.02) | Non-systematic Assessment | In 9-year-old with history of neurologic disorder who received FluzoneHD after recovery from sedation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon McCullers, MD | St. Jude Children's Research Hospital | 866-278-5833 | info@stjude.org |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| HIV-SD | Active Comparator | Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses. |
|
|
| Fluzone Standard Dose Vaccine | Biological | Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV. |
|
|
| Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD |
The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease. The immune response of 1 dose vs. 2 doses of Fluzone HD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10. |
| at least 21 days after each dose of vaccine |
| Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD | The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease. The immune response of 1 dose vs. 2 doses of Fluzone SD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10. | at least 21 days after each dose of vaccine |
| Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC) | The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables. | ALC at baseline and vaccine response at least 21 days after last dose of vaccine |
| Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC) | The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables. | ALC at baseline and vaccine response at least 21 days after last dose of vaccine |
| Number of Local Reactogenicity Events After First Dose | Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration. | First 14 days after vaccination |
| Number of Local Reactogenicity Events After Second Dose | Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration. | First 14 days after vaccination |
| Number of Systemic Reactogenicity Events After First Dose | Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever. | First 14 days after vaccination |
| Number of Systemic Reactogenicity Events After Second Dose | Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever. | First 14 days after vaccination |
| Comparison of Geometric Mean Titer (GMT) by HAI | Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro. | Pre-vaccination, post-vaccination and 9 months after vaccination |
| Comparison of Geometric Mean Ratios (GMR) by HAI | GMTs compared to each other as a ratio of the pre- and post-vaccine titers and as the ratio post-last dose to 9 months later. GMRs were compared pre- to post-vaccination and post- vaccination to 9 months later. | Pre-vaccination, post-vaccination and 9 months after vaccination |
| BG002 | Solid Tumor-HD | Patients with a diagnosis of solid tumor who received the high dose Fluzone HD. |
| BG003 | Solid Tumor-SD | Patients with a diagnosis of solid tumor who received the standard dose Fluzone. |
| BG004 | HIV-HD | Patients with a diagnosis of HIV who received the high dose Fluzone HD. |
| BG005 | HIV-SD | Patients with a diagnosis of HIV who received the standard dose Fluzone. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Leukemia-SD |
Patients with a diagnosis of leukemia who received the standard dose Fluzone. |
| OG002 | Solid Tumor-HD | Patients with a diagnosis of solid tumor who received the high dose Fluzone HD. |
| OG003 | Solid Tumor-SD | Patients with a diagnosis of solid tumor who received the standard dose Fluzone. |
| OG004 | HIV-HD | Patients with a diagnosis of HIV who received the high dose Fluzone HD. |
| OG005 | HIV-SD | Patients with a diagnosis of HIV who received the standard dose Fluzone. |
|
|
| Secondary | Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD | Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD. | Adverse events of Fluzone HD and Fluzone are provided as combined data from cancer and HIV patients, since there is no reason to believe one group is more susceptible to adverse events than the other. | Posted | Number | participants | From initial vaccine administration through up to 8 months |
|
|
|
| Secondary | Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD | The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease. The immune response of 1 dose vs. 2 doses of Fluzone HD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10. | Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response. | Posted | Number | percentage of participants | at least 21 days after each dose of vaccine |
|
|
|
| Secondary | Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD | The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease. The immune response of 1 dose vs. 2 doses of Fluzone SD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10. | Posted | Number | percentrage of participants | at least 21 days after each dose of vaccine |
|
|
|
| Secondary | Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC) | The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables. | 30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count. | Posted | Number | percentagae of participants | ALC at baseline and vaccine response at least 21 days after last dose of vaccine |
|
|
|
|
| Primary | Rate of Seroprotection After 1 Dose of Vaccine | The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40. | Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response. | Posted | Number | Percentage of participants | at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose |
|
|
|
| Primary | Number of Participants Achieving Seroprotection After Second Dose of Vaccine | The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40. | Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response. | Posted | Number | number of participants | 21 to 42 days after second dose |
|
|
|
| Secondary | Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC) | The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables. | 30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count. | Posted | Number | percentage of participants | ALC at baseline and vaccine response at least 21 days after last dose of vaccine |
|
|
|
|
| Secondary | Number of Local Reactogenicity Events After First Dose | Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration. | Posted | Number | Events | First 14 days after vaccination |
|
|
|
|
| Secondary | Number of Local Reactogenicity Events After Second Dose | Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration. | Posted | Number | Events | First 14 days after vaccination |
|
|
|
|
| Secondary | Number of Systemic Reactogenicity Events After First Dose | Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever. | Posted | Number | Events | First 14 days after vaccination |
|
|
|
|
| Secondary | Number of Systemic Reactogenicity Events After Second Dose | Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever. | Posted | Number | Events | First 14 days after vaccination |
|
|
|
|
| Secondary | Comparison of Geometric Mean Titer (GMT) by HAI | Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro. | Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response. | Posted | Geometric Mean | Full Range | Titers | Pre-vaccination, post-vaccination and 9 months after vaccination |
|
|
|
| Secondary | Comparison of Geometric Mean Ratios (GMR) by HAI | GMTs compared to each other as a ratio of the pre- and post-vaccine titers and as the ratio post-last dose to 9 months later. GMRs were compared pre- to post-vaccination and post- vaccination to 9 months later. | Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response. | Posted | Number | Ratio | Pre-vaccination, post-vaccination and 9 months after vaccination |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Leukemia-SD | Patients with a diagnosis of leukemia who received the standard dose Fluzone. | 0 | 13 | 0 | 13 |
| EG002 | Solid Tumor-HD | Patients with a diagnosis of solid tumor who received the high dose Fluzone HD. | 1 | 8 | 0 | 8 |
| EG003 | Solid Tumor-SD | Patients with a diagnosis of solid tumor who received the standard dose Fluzone. | 0 | 9 | 0 | 9 |
| EG004 | HIV-HD | Patients with a diagnosis of HIV who received the high dose Fluzone HD. | 0 | 20 | 0 | 20 |
| EG005 | HIV-SD | Patients with a diagnosis of HIV who received the standard dose Fluzone. | 0 | 20 | 0 | 20 |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| H3 antigen |
|
| B antigen |
|
| H3 antigen |
|
| B antigen |
|
| H3 antigen |
|
| B antigen |
|
| H3 antigen |
|
| B antigen |
|
| H1 Antigen/Post-vaccination |
|
| H1 Antigen/9 Months Post-vaccination |
|
| H3 Antigen/Pre-vaccination |
|
| H3 Antigen/Post-vaccination |
|
| H3 Antigen/9 Months Post-vaccination |
|
| B Antigen/Pre-vaccination |
|
| B Antigen/Post-vaccination |
|
| B Antigen/9 Months Post-vaccination |
|
| H1 post-vaccination over 9 months |
|
| H3 post- over pre-vaccination |
|
| H3 post-vaccination over 9 months |
|
| B post- over pre-vaccination |
|
| B post-vaccination over 9 months |
|