Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
164 participants
OBSERVATIONAL
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Year 1 Group 1
They are between 18-65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
Influenza Virus Vaccine
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Year 1 Group 2
They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
Influenza Virus Vaccine
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Year 1 Group 3
They are between 18-65 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
Influenza Virus Vaccine
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Year 1 Group 4
They are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
Influenza Virus Vaccine
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Year 1 Group 5
They are between 35-50 years of age, meet the criteria listed above for non-diabetic subjects in Group 1, with the exception of chronic HIV with or without hepatitis B or C infection, and have current medical history of CD4 T-cell counts 300-800.
Influenza Virus Vaccine
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Year 2 Group 1
They are between 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
No interventions assigned to this group
Year 2 Group 2
They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
No interventions assigned to this group
Year 2 Group 3
If they are between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
No interventions assigned to this group
Year 2 Group 4
If they are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
No interventions assigned to this group
Interventions
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Influenza Virus Vaccine
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Group 2: Must be ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
* Group 3: Must be between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
* Group 4: Must be ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
* Group 5: Must be between 35-50 years of age, meet the criteria listed above for non-diabetic subjects in Group 1, with the exception of chronic HIV with or without hepatitis B or C infection, and have current medical history of CD4 T-cell counts 300-800.
* a history of a bleeding disorder or received anticoagulants within the last 3 weeks
* received the influenza vaccine in the past 6 months or any other vaccines within the last 3 months
* received immunosuppressive therapy within the last 6 months
* received long-term systemic corticosteroid therapy for more than 2 consecutive weeks within 3 months
* received blood or blood-derived products within the last 3 months
* a daily aspirin intake of \>81mg
* a blood pressure \>150/95 at screening
Group 1: They are between 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
Group 2: They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
Group 3: If they are between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
NOTE: Current diabetes is defined by patient report of physician diagnosis. Subjects with a history of diabetes which has resolved and no longer requires therapy are not considered to have current diabetes, e.g, women with a history of gestational diabetes, steroid-induced or medication-induced.
Group 4: If they are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
Year 2 Subjects will be excluded if they have any of the following:
* a history of known or suspected impairment of immunologic function, including clinically significant liver disease, arthritis, moderate to severe renal (kidney) disease, HIV, and ongoing infections
* a history of a bleeding disorder or received anticoagulants within the last 3 weeks
* a history of heart failure
* a history of receiving immunosuppressive therapy within the last 6 months
* a history of receiving long-term systemic corticosteroid therapy for more than 2 consecutive weeks within 3 months
* a history of receiving blood or blood-derived products within the last 3 months
* a daily aspirin intake of \>325mg
* are pregnant
Exclusion Criteria
* a history of Guillain-Barré syndrome
18 Years
ALL
Yes
Sponsors
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Louisiana Clinical and Translational Science Center
OTHER
Tulane University
OTHER
Responsible Party
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Elizabeth Norton
Assistant Professor
Principal Investigators
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Elizabeth B Norton, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Tulane University School of Medicine
Locations
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Tulane Clinical Translational Unit
New Orleans, Louisiana, United States
Countries
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Other Identifiers
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15-727936
Identifier Type: -
Identifier Source: org_study_id
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