Vaccine Adverse ReactionNCT05178264
Transverse Myelitis Related to SARS-CoV-2 Vaccines
An observational study of Vaccine Adverse Reaction, run by University Hospital, Caen at 1 site in France.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccine Adverse Reaction
- What is being tested?
- SARS-CoV-2 vaccines
- Type of treatment
- Vaccines
- How many people
- 580 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2021to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients
Who may be able to join
- case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaccine Adverse Reaction
- Being tested
- SARS-CoV-2 vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 vaccinesDrug
Also called (ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson & Johnson))
All patients treated at least with 1 SARS-CoV-2 vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
TM reportes related to SARS-CoV-2 vaccine
Measured: 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.
Measured: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
Description of the outcomes following TM
Measured: 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
Measured: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start10 Dec 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Adverse ReactionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178264
- Sponsor's protocol ID
- Pharmaco 20211210
- Status last verified
- Dec 2021
- First submitted
- 3 Jan 2022
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Myelitis Related to SARS-CoV-2 Vaccines in Patients: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database
- ClinicalTrials.gov ID
- NCT05178264
- Acronym / sponsor ID
- Pharmaco 20211210
- Conditions
- Vaccine Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients
Key inclusion criteria (1 listed)
- case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 vaccinesAlso: (ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson & Johnson))All patients treated at least with 1 SARS-CoV-2 vaccine | Drug | – |
Primary outcome
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
3 secondary outcomes
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
Description of the outcomes following TM
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Adverse Reaction, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.