| identifier: | SDY618 |
| description: |
This is a single center, open-label, mechanistic study designed to determine the variance of the antibody response in non-atopic and ADEH- participants receiving a single dose of the 2011-2012 seasonal Fluzone Intradermal vaccine administered per label.
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| aggregation: |
instance of dataset
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| refinement: |
2 - Complete set of descriptive data and results, as ascertained by ImmPort.
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| availability: |
available with registration
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| isAbout: |
The primary objective of this study is to estimate the variance of the log fold change from baseline in HAI antibody titers for non-atopic controls and ADEH- participants, following administration per label of a single dose of the seasonal 2011-2012 Fluzone Intradermal vaccine.
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| authorizations: |
registration required
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| accessURL: |
https://clinicaltrials.gov/ct2/show/NCT01518478 https://aspera-immport.niaid.nih.gov:9443/browser?path=SDY618 |
| landingPage: |
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY618 |
| clinical trial: | |
| study category: | Vaccine Response |
| study type: | Interventional |
| subject species: | Homo sapiens |
| biosample type: | |
| subject gender: | Both |
| assay type: |
| name: |
Atopic Dermatitis
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| fullName: |
Donald Leung
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| affiliations: |
National Jewish Health
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| roles: |
principal investigator
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| name: |
ADRN Influenza Vaccine Pilot (ADRN-03)
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| size: |
40
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| name: |
Atopic Dermatitis & Vaccinia Network (ADVN) Clinical Studies Consortium
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| output: |
HAI antibody titers against each strain of influenza present in the vaccine will be measured from serum samples collected before vaccination on Day 0 (Baseline) and post-vaccination on Day 28.
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| studyGroups: |
ADEH- (mild to severe AD): Atopic Dermatitis without previous or current Eczema Herpeticum
Non-atopic: Non-atopic, healthy control
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| description: |
A new flu vaccine which is injected into the skin instead of into the muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis (AD). This new vaccine has been shown to work as well as the vaccine which is injected into muscle when tested in people without atopic dermatitis. The primary endpoint of the study is to estimate the variance of the log fold change from baseline in HAI antibody titers for non-atopic controls and participants with atopic dermatitis without a history of eczema herpeticum (ADEH-), following administration of a single dose of the seasonal 2011-2012 Fluzone Intradermal vaccine.
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| identifier: |
10.21430/M3AFZ310EE
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| startDate: |
2011-11-01
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| name: |
ImmPort
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| identifier: |
SCR:012804
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| homePage: |
http://www.immport.org |