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Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)

Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04236193
Acronym
SIRVA
Enrollment
30
Registered
2020-01-22
Start date
2018-04-01
Completion date
2019-12-31
Last updated
2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosion, Localized, Shoulder Injury Related to Vaccine Administration

Brief summary

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.

Interventions

DIAGNOSTIC_TESTUltrasound Shoulder and Immunological Phenotyping by FACS

Cross-sectional Ultrasound exam of the affected shoulder. Peripheral blood measurements of the T and B cell subsets. Anti-Influenza Antibody measurements

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* participation at a local vaccination campaign * Shoulder pain \>3 days after vaccination

Exclusion criteria

* no vaccine received * preexisting shoulder pathology

Design outcomes

Primary

MeasureTime frameDescription
Pathological Findings in UltrasoundUltrasound of the shoulder is performed at Baseline/InclusionCross-sectional assessment and description of pathological ultrasound findings in subjects with shoulder pain after influenza vaccination

Secondary

MeasureTime frameDescription
Increased Vaccine responseBaseline and 12 monthsAntibodies against Influenza, Plasmablasts and T follicular helper cell increase

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026