Transverse Myelitis Related to SARS-CoV-2 Vaccines

Completed

• Conditions: Vaccine Adverse Reaction

• Registration Number: NCT05178264
• Lead Sponsor: University Hospital, Caen

Brief 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.

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 Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-10
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-03
• Last Update Submitted: 2022-01-03
• Study First Posted: 2022-01-05
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Description of the outcomes following TM	date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
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

Trial Locations

Locations (1)

Alexandre Joachim; 🇫🇷 Caen, Basse Normandie, France