Transverse Myelitis Related to SARS-CoV-2 Vaccines

NCT05178264 | Completed FDA Drug

• 1 other identifier: Pharmaco 20211210
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Description of the outcomes following TM

  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

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

Interventions

SARS-CoV-2 vaccines DRUG

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

Location

MeSH Terms

Interventions

COVID-19 Vaccines; BNT162 Vaccine; 2019-nCoV Vaccine mRNA-1273; Ad26COVS1

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 5, 2022
• Study Start: December 10, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)