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NCT05234333
COVID-19 Vaccines Associated Malaise
trial testing SARS-CoV-2 vaccine in Vaccine Adverse Reaction in 1,534,706 participants. Completed in 26 January 2022.
26 January 2022
Quick facts
| Lead sponsor | University Hospital, Caen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,534,706 |
| Start date | 1 January 2021 |
| Primary completion | 26 January 2022 |
| Estimated completion | 26 January 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- SARS-CoV-2 vaccine — full drug profile →
Conditions studied
- Vaccine Adverse Reaction — all drugs for Vaccine Adverse Reaction →
Sponsor
University Hospital, Caen
Who can join
Eligibility, any sex, with Vaccine Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05234333
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SARS-CoV-2 vaccine
Trials testing the same drug.
- NCT04866069 — Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults · Phase 1 · terminated
- NCT04895475 — Antibody Detection of Vaccine-Induced Secretory Effects · completed
- NCT04747522 — Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Immune Kidney Transplant Study (COVID-19) · active not recruiting
Other recruiting trials for Vaccine Adverse Reaction
Currently open trials in the same condition.
- NCT06180447 — Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes · active not recruiting
- NCT05898464 — Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV · Phase 4 · active not recruiting
- NCT06286488 — Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza · Phase 4 · active not recruiting
Other University Hospital, Caen trials
Trials by the same sponsor.
- NCT07406737 — Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing · not yet recruiting
- NCT06639750 — Respiratory Microbioma and Respiratory Complications After Hematopoietic Stem Cell Transplantion · not yet recruiting
- NCT07467031 — Bachstim Registry: a Feasability Study of Bachmann's Area Pacing · not yet recruiting
- NCT07477132 — A Dose-response Study to Determine the Right Dosage of Sugammadex as a Reversal Agent of Rocuronium in Infants Between 1 · Phase 4 · not yet recruiting
- NCT07520578 — EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WI · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05234333 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Caen
- Last refreshed: 5 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05234333.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing