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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05167 | Other Identifier | NCI Clinical Trials Reporting Program |
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Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. The study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (Flu) vaccine.
Primary Objective
Secondary Objectives
Exploratory Objectives
This is a prospective, 2-stage, non-therapeutic study to characterize the immunogenicity of influenza vaccination among pediatric oncology patients at St. Jude. The first stage of the study will consist of a feasibility phase to assess the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. The second stage will assess the immunogenicity of IIV among pediatric leukemia patients in a larger samples size. The investigator will collect about one teaspoon of blood from the study participant up to 6 times over a year for a total of 6 teaspoons a year. The investigator will also collect some information about the study participant's underlying condition, flu testing and overall health from the medical record during this time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Influenza Vaccine Recipients | Pediatric patients eligible to receive seasonal influenza vaccine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of evaluable participants. | Feasibility is estimated as the proportion of evaluable patients who provide a baseline and Day +35 sample. A 95% confidence interval will be provided. | 3 years |
| Proportion of participants with immunogenicity 3 to 5 weeks following vaccination. | Immunogenecity will be measured by the development of cell- and antibody-mediated influenza specific responses 3 to 5 weeks following vaccination. Immunogenicity is estimated as the proportion of evaluable patients whose cell- (as measured by development of any detectable specific T cell responses) and antibody-mediated influenza specific responses (as measured by detectable post vaccination antibody titers) 3 to 5 weeks following vaccination. 95% confidence intervals will be provided. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with an immune response 1 to 2 weeks following vaccination. | The proportion of patients who have detectable cell- and antibody-mediated influenza specific responses 1-2 weeks following vaccination will be estimated along with a 95% confidence interval. | 3 years |
| Proportion of participants with durability of immunogenicity at 6 months and 1 year post-vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
• Previously received at least one dose of the current seasonal influenza vaccine.
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All participants who meet eligible criteria and consent to enrollment on the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramilo Octavio, MD | Contact | 866-278-5833 | referralinfo@stjude.org |
| Name | Affiliation | Role |
|---|---|---|
| Ramilo Octavio, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Recruiting | 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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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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The proportion of patients who still have detectable cell- and antibody-mediated influenza specific responses 6 months and 1 year following vaccination will be estimated, respectively. 95% confidence intervals will be provided |
| 3 years |