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OpenTrials
Completed

NCT Number: NCT05178264

Transverse Myelitis Related to SARS-CoV-2 Vaccines

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.

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Key information

Conditions

Vaccine Adverse Reaction

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandre Joachim

Caen, Basse Normandie, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SARS-CoV-2 vaccines

Drug

All patients treated at least with 1 SARS-CoV-2 vaccine

Other names: (ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson & Johnson))

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Description of the outcomes following TM

    Time frame: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2022
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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