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OpenTrials
Completed

NCT Number: NCT05234333

COVID-19 Vaccines Associated Malaise

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.

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Key information

Conditions

Vaccine Adverse Reaction

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • all adverse events reported in the WHO pharmacovigilance database

Exclusion criteria

  • none

Treatment and study plan

SARS-CoV-2 vaccine

Drug

SARS-CoV-2 vaccination

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

COVID-19 Vaccines Induced Malaise: A Retrospective Study and Analysis of the WHO Pharmacovigilance Database

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2022
Registry last updated
May 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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