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NCT05178264 Clinical Trial

Transverse Myelitis Related to SARS-CoV-2 Vaccines

Vaccine Adverse Reaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05178264
Other study ID # Pharmaco 20211210
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 10, 2021
Est. completion date December 10, 2021

Study information
Verified date December 2021
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 580
Est. completion date December 10, 2021
Est. primary completion date December 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• SARS-CoV-2 vaccines
All patients treated at least with 1 SARS-CoV-2 vaccine

Locations
Country Name City State
France Alexandre Joachim Caen Basse Normandie

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

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