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Accidental vaccine injection into adjunct shoulder structures can cause tissue damage, termed Shoulder injury related to vaccine administration (SIRVA). The immunopathological mechanisms and consequences of SIRVA are unknown.
The study assesses the clinical and immunological consequences of an influenza vaccine if accidentally administered in periarticular space.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIRVA | Subjects with shoulder pain >7 days after vaccination |
| |
| Controls | Subjects from a prospective influenza vaccine study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Shoulder and Immunological Phenotyping by FACS | Diagnostic Test | Cross-sectional Ultrasound exam of the affected shoulder. Peripheral blood measurements of the T and B cell subsets. Anti-Influenza Antibody measurements |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Findings in Ultrasound | Cross-sectional assessment and description of pathological ultrasound findings in subjects with shoulder pain after influenza vaccination | Ultrasound of the shoulder is performed at Baseline/Inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Increased Vaccine response | Antibodies against Influenza, Plasmablasts and T follicular helper cell increase | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects receiving the Influenza vaccine at a local vaccination campaign in Basel, Switzerland
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Berger, MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Switzerland |
Data on flowcytometry based immunophenotyping
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