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Infections due to influenza and pneumococcus can be very serious and cause death. Anyone can get these infections. However, some people are at greater risk from the disease, including people 65 and older, the very young, and people with special health problems such as people with certain types of cancer, heart, lung, or kidney disease, or diabetes. Influenza can cause a very serious lung infection (pneumonia) and increase the risk of stroke and heart attacks. Pneumococcal disease can lead to serious infections in the lungs (pneumonia), the blood (bacteremia), and the covering of the brain (meningitis). People with the special health problems mentioned above are even more likely to die from the disease. Although there are drugs to treat these infections, they are not always effective. This makes prevention of the disease through vaccination even more important.
This study will look at the body's response to influenza and pneumococcal vaccination. We want to see how well they it will protect. Immunization is the same as vaccination. Our goal is to protect as much as we can. We are doing the study because more information is needed to see how well older patients with cancer respond to these vaccines and how well they protect against disease caused by influenza and pneumococcus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, | Experimental | Patients > or = to 65 years of age with a diagnosis of prostate, lung, and/or breast cancer will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or the 23 valent pneumococcal vaccine (0.5 ml subcutaneously or intramuscularly). |
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| 2 | Experimental | MSKCC employee volunteer controls > or = to 65 years of age without a cancer diagnosis will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or PPV23 vaccine (Pneumovax), (0.5 ml subcutaneously or intramuscularly). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inactivated influenza vaccine and the 23- valent pneumococcal vaccine | Biological | Patients >65 years of age with a diagnosis of prostate, lung, and/or breast cancer will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or the 23-valent pneumococcal vaccine (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured, as will serum IgG levels and IgG subtypes. At 8-16 weeks after vaccination, post vaccine titers, CBC, lymphoid phenotype and function will be assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine Response Rate of Patients > or = to 65 Yrs Diagnosed | For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V). | 8-16 weeks following vaccination. |
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Inclusion Criteria:
Volunteer eligibility:
Exclusion Criteria:
Healthy controls exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Trudy Small, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Cancer Patients 65 Years of Age and Older | Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older |
| FG001 | Healthy Volunteers |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| inactivated influenza vaccine and the PPV23 vaccine (Pneumovax) | Biological | MSKCC employee volunteer controls > or = to 65 years of age without a cancer diagnosis will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly)and/or PPV23 vaccine (Pneumovax), (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured. At approximately 8-16 weeks after vaccination, post vaccine titers will be measured again. |
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Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Cancer Patients 65 Years of Age and Older | Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older |
| BG001 | Healthy Volunteers | Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older |
| 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | 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 | Determine Response Rate of Patients > or = to 65 Yrs Diagnosed | For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V). | Posted | Number | participants | 8-16 weeks following 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 | Adult Cancer Patients 65 Years of Age and Older | Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older | 0 | 95 | 0 | 95 | ||
| EG001 | Healthy Volunteers | Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Seo | Memorial Sloan Kettering Cancer Center | 212-639-3151 | seos@mskcc.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| >=65 years |
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| Male |
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