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To study the effects of age on the immune system's response to flu vaccine and to study the connection between the immune system and physical and cognitive changes associated with aging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzone-High Dose | Active Comparator | FDA approved high dose inactivated influenza vaccine (HD-Fluzone) |
|
| Fluad | Active Comparator | Adjuvanted (MF59) inactivated influenza vaccine (Fluad) |
|
| Recombinant Hemagglutinin vaccine (Flublok) | Active Comparator | Recombinant hemagglutinin vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone-High Dose Quadrivalent | Biological | Seasonal influenza vaccination with FDA approved vaccines for this age group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutinin Antigen Inhibition Assay Titers at Baseline | 2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam)) | Baseline Baseline |
| Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | 2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam)) | Day 28 Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Spyros Kalams | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37211 | United States |
All relevant findings will be published in peer-reviewed journals and data generated will be presented at national and international meetings. research articles will be deposited in the NIH National Library of Medicine's PubMed Central upon acceptance for publication.
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All relevant findings will be published in peer-reviewed journals and data generated will be presented at national and international meetings. Research articles will be deposited in the NIH National Library of Medicine's PubMed Central upon acceptance for publication. To the extent possible,we will make raw data available in publications (directly or online appendices). If novel techniques are developed and validated, these methods will be shared with the general scientific community in a timely fashion, and also made available via the protocols.io open access platform. As suggested by the NIH , this will be no later than the acceptance for publication of the main findings from the final data set generated within this proposal. If requests for access to data beyond that in our publications are made by members of the scientific community, we will ask that users submit requests for specific analyses, and we will strive to meet all reasonable requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone-High Dose | FDA approved high dose inactivated influenza vaccine (HD-Fluzone) Fluzone-High Dose Quadrivalent: Seasonal influenza vaccination with FDA approved vaccines for this age group. |
| FG001 | Fluad | Adjuvanted (MF59) inactivated influenza vaccine (Fluad) Fluad: Adjuvanted (MF59) inactivated influenza vaccine |
| FG002 | Recombinant Hemagglutinin Vaccine (Flublok) | Recombinant hemagglutinin vaccine Flublock: Recombinant hemagglutinin vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone-High Dose | FDA approved high dose inactivated influenza vaccine (HD-Fluzone) Fluzone-High Dose Quadrivalent: Seasonal influenza vaccination with FDA approved vaccines for this age group. |
| BG001 | Fluad |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | 2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam)) | 1 person in Fluzone HD group received vaccine, but did not return for subsequent visits, so titers were not performed for this participant. | Posted | Median | Inter-Quartile Range | antibody titers | Baseline Baseline |
|
Baseline to day 28
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
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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 | Fluzone-High Dose | FDA approved high dose inactivated influenza vaccine (HD-Fluzone) Fluzone-High Dose Quadrivalent: Seasonal influenza vaccination with FDA approved vaccines for this age group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Spyros Kalams, MD | Vanderbilt University Medical Center | 6153222035 | Joan.e.eason@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2019 | Dec 1, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2019 | Dec 1, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| 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 |
| C478243 | fluad vaccine |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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This is an open label trial, the study nurse and participant know which of 3 FDA approved influenza vaccines are given (Fluzone-HD, FluAd, or Flublok). However the investigator and outcomes assessor are blinded to the actual vaccine given.
| Fluad | Biological | Adjuvanted (MF59) inactivated influenza vaccine |
|
|
| Flublock | Biological | Recombinant hemagglutinin vaccine |
|
|
Adjuvanted (MF59) inactivated influenza vaccine (Fluad)
Fluad: Adjuvanted (MF59) inactivated influenza vaccine
| BG002 | Recombinant Hemagglutinin Vaccine (Flublok) | Recombinant hemagglutinin vaccine Flublock: Recombinant hemagglutinin vaccine |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Adjuvanted (MF59) inactivated influenza vaccine (Fluad) Fluad: Adjuvanted (MF59) inactivated influenza vaccine |
| OG002 | Recombinant Hemagglutinin Vaccine (Flublok) | Recombinant hemagglutinin vaccine Flublock: Recombinant hemagglutinin vaccine |
|
|
| Primary | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | 2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam)) | 1 person in Fluzone HD group received vaccine, but did not return for subsequent visits, so titers were not performed for this participant. | Posted | Median | Inter-Quartile Range | antibody titers | Day 28 Baseline |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Fluad | Adjuvanted (MF59) inactivated influenza vaccine (Fluad) Fluad: Adjuvanted (MF59) inactivated influenza vaccine | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Recombinant Hemagglutinin Vaccine (Flublok) | Recombinant hemagglutinin vaccine Flublock: Recombinant hemagglutinin vaccine | 0 | 6 | 0 | 6 | 0 | 6 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| A/Kansas/2017 (H3N2) |
|
|
| B/Colorado/2017 (Vic) |
|
|
| B/Phuket/2013 (Yam) |
|
|