Transverse Myelitis Related to SARS-CoV-2 Vaccines

January 3, 2022 updated by: University Hospital, Caen

Transverse Myelitis Related to SARS-CoV-2 Vaccines in Patients: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database

Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce.

The objective was to investigate reports of TM adverse events related to SARS-CoV-2 vaccines labelled by FDA and EMA, including ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson & Johnson) and using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of TM related to SARS-CoV-2 vaccines.

Study Type

Observational

Enrollment (Actual)

580

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

  • France
    • Basse Normandie
      • Caen, Basse Normandie, France, 14000
        • Alexandre Joachim

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients

Description

Inclusion Criteria:

- case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,

Exclusion Criteria:

  • chronology not compatible between the SARS-CoV-2 vaccine adminisration and onset of TM.
  • vaccines non-labelled by FDA/EMA (data cutoff december 10, 2021)

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: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TM reportes related to SARS-CoV-2 vaccine
Time Frame: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021

Secondary Outcome Measures

Outcome Measure
Time Frame
Description of the latency period since SARS-CoV-2 vaccine exposure.
Time Frame: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
Description of the outcomes following TM
Time Frame: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
Description of patients who experienced co-reported adverse events
Time Frame: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021

Collaborators and Investigators

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

Sponsor

University Hospital, Caen

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)

December 10, 2021

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

December 10, 2021

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pharmaco 20211210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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