MedTrace Logo

COVID-19 Vaccines Associated Malaise

NCT05234333 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1534706

Last updated 2022-05-05

No results posted yet for this study

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.

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

Interventions

DRUG

SARS-CoV-2 vaccine

SARS-CoV-2 vaccination

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-01-26
Completion
2022-01-26
FDA Drug
Yes

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234333 on ClinicalTrials.gov