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

January 16, 2020 updated by: Christoph Berger, University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects receiving the Influenza vaccine at a local vaccination campaign in Basel, Switzerland

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no vaccine received
  • preexisting shoulder pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SIRVA
Subjects with shoulder pain >7 days after vaccination
Diagnostic test: Ultrasound 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
Controls
Subjects from a prospective influenza vaccine study
Diagnostic test: Ultrasound 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Findings in Ultrasound
Time Frame: 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
Ultrasound of the shoulder is performed at Baseline/Inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased Vaccine response
Time Frame: Baseline and 12 months
Antibodies against Influenza, Plasmablasts and T follicular helper cell increase
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Christoph Berger, MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

November 15, 2019

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIRVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data on flowcytometry based immunophenotyping

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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