Shoulder Injury Related to Vaccine AdministrationSIRVANCT04236193
Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)
An observational study of Shoulder Injury Related to Vaccine Administration and Erosion, Localized, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Injury Related to Vaccine Administration, Erosion, Localized
- What is being tested?
- Ultrasound Shoulder and Immunological Phenotyping by FACS
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2018to 31 Dec 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects receiving the Influenza vaccine at a local vaccination campaign in Basel, Switzerland
Who may be able to join
- participation at a local vaccination campaign
- Shoulder pain >3 days after vaccination
Who cannot join
- no vaccine received
- preexisting shoulder pathology
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Ultrasound Shoulder and Immunological Phenotyping by FACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Shoulder and Immunological Phenotyping by FACSDiagnostic test
Cross-sectional Ultrasound exam of the affected shoulder. Peripheral blood measurements of the T and B cell subsets. Anti-Influenza Antibody measurements
| Study group | Role | What they receive |
|---|---|---|
| SIRVA | Subjects with shoulder pain >7 days after vaccination Receives: Diagnostic Test: Ultrasound Shoulder and Immunological Phenotyping by FACS | |
| Controls | Subjects from a prospective influenza vaccine study Receives: Diagnostic Test: Ultrasound Shoulder and Immunological Phenotyping by FACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Findings in Ultrasound
Cross-sectional assessment and description of pathological ultrasound findings in subjects with shoulder pain after influenza vaccination
Measured: Ultrasound of the shoulder is performed at Baseline/Inclusion
Secondary outcomes (1)
Increased Vaccine response
Antibodies against Influenza, Plasmablasts and T follicular helper cell increase
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Apr 2018
- Primary completion30 Nov 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Injury Related to Vaccine AdministrationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Berger, University Hospital, Basel, Switzerland
- Investigators
- Christoph Berger, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236193
- Sponsor's protocol ID
- SIRVA
- Acronym
- SIRVA
- Status last verified
- Jan 2020
- First submitted
- 15 Nov 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data on flowcytometry based immunophenotyping
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Immunological Findings in Patients With Shoulder Injury Related to Vaccine Administration (SIRVA)
- ClinicalTrials.gov ID
- NCT04236193
- Acronym / sponsor ID
- SIRVA / SIRVA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIRVA | – | Diagnostic Test: Ultrasound Shoulder and Immunological Phenotyping by FACSSubjects with shoulder pain >7 days after vaccination |
| Controls | – | Diagnostic Test: Ultrasound Shoulder and Immunological Phenotyping by FACSSubjects from a prospective influenza vaccine study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects receiving the Influenza vaccine at a local vaccination campaign in Basel, Switzerland
Key inclusion criteria (2 listed)
- participation at a local vaccination campaign
- Shoulder pain >3 days after vaccination
Key exclusion criteria (2 listed)
- no vaccine received
- preexisting shoulder pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Shoulder and Immunological Phenotyping by FACSCross-sectional Ultrasound exam of the affected shoulder. Peripheral blood measurements of the T and B cell subsets. Anti-Influenza Antibody measurements | Diagnostic test | Controls, SIRVA |
Primary outcome
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
1 secondary outcome
Increased Vaccine response
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Undecided. Data on flowcytometry based immunophenotyping
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Berger, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Injury Related to Vaccine Administration and Erosion, Localized, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Findings in Ultrasound (time frame: Ultrasound of the shoulder is performed at Baseline/Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.