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

Completed

• Conditions: Shoulder Injury Related to Vaccine Administration; Erosion, Localized
• Interventions: Diagnostic Test: Ultrasound Shoulder and Immunological Phenotyping by FACS

• Registration Number: NCT04236193
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-11-30
• Study First Submitted: 2019-11-15
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-16
• Study First Posted: 2020-01-22
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• no vaccine received
• preexisting shoulder pathology

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SIRVA	Ultrasound Shoulder and Immunological Phenotyping by FACS	Subjects with shoulder pain \>7 days after vaccination
Controls	Ultrasound Shoulder and Immunological Phenotyping by FACS	Subjects from a prospective influenza vaccine study

Primary Outcome Measures

Name	Time	Method
Pathological Findings in Ultrasound	Ultrasound of the shoulder is performed at Baseline/Inclusion	Cross-sectional assessment and description of pathological ultrasound findings in subjects with shoulder pain after influenza vaccination

Secondary Outcome Measures

Name	Time	Method
Increased Vaccine response	Baseline and 12 months	Antibodies against Influenza, Plasmablasts and T follicular helper cell increase

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland