Vaccine Adverse ReactionNCT05234333
COVID-19 Vaccines Associated Malaise
An observational study of Vaccine Adverse Reaction, run by University Hospital, Caen at 1 site in France.
Trial summary
COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines could be more prone to cause malaise compared to influenza vaccines. 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 vaccine
- Type of treatment
- Vaccines
- How many people
- 1,534,706 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 26 Jan 2022
- 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
- all adverse events reported in the WHO pharmacovigilance database
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site
Caen University Hospital, Department of Pharmacology
Caen, Normandy, 14033
About this study
Official title: COVID-19 Vaccines Induced Malaise: A Retrospective Study and Analysis of the WHO Pharmacovigilance Database
COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines could be more prone to cause malaise compared to influenza vaccines.
To do so we performed a disproportionality analysis adjusted on age class, sex, region and type of reporter in VigiBase®, the WHO pharmacovigilance database, restricted to data from 01/01/2021 to 26/01/2022 to assess the association between all COVID-19 vaccines on the market and malaise. Demographic data were also analyzed.
- Conditions
- Vaccine Adverse Reaction
- Being tested
- SARS-CoV-2 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 vaccineDrug
SARS-CoV-2 vaccination
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting a malaise after the vaccination by any vaccine | Not described Receives: Drug: SARS-CoV-2 vaccine | |
| Patients presenting any other adverse event after the vaccination by any vaccine | Not described Receives: Drug: SARS-CoV-2 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines
case/no case study
Measured: from the 01/01/2021 to the 26/01/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jan 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
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
- 1,534,706 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
- NCT05234333
- Sponsor's protocol ID
- Pharmaco 20220203
- Status last verified
- Apr 2022
- First submitted
- 9 Feb 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccines Induced Malaise: A Retrospective Study and Analysis of the WHO Pharmacovigilance Database
- ClinicalTrials.gov ID
- NCT05234333
- Acronym / sponsor ID
- Pharmaco 20220203
- Conditions
- Vaccine Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,534,706 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 10 Feb 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.
COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines could be more prone to cause malaise compared to influenza vaccines.
To do so we performed a disproportionality analysis adjusted on age class, sex, region and type of reporter in VigiBase®, the WHO pharmacovigilance database, restricted to data from 01/01/2021 to 26/01/2022 to assess the association between all COVID-19 vaccines on the market and malaise. Demographic data were also analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients presenting a malaise after the vaccination by any vaccine | – | Drug: SARS-CoV-2 vaccine |
| Patients presenting any other adverse event after the vaccination by any vaccine | – | Drug: SARS-CoV-2 vaccine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients
Key inclusion criteria (1 listed)
- all adverse events reported in the WHO pharmacovigilance database
Key exclusion criteria (1 listed)
- none
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 vaccineSARS-CoV-2 vaccination | Drug | Patients presenting a malaise after the vaccination by any vaccine, Patients presenting any other adverse event after the vaccination by any vaccine |
Primary outcome
disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines
Time frame: from the 01/01/2021 to the 26/01/2022
case/no case study
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 May 2022.
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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 1 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 May 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?
disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines (time frame: from the 01/01/2021 to the 26/01/2022). 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 May 2022.