COVID-19 Vaccines Associated Malaise

NCT05234333 | Completed FDA Drug

• 1 other identifier: Pharmaco 20220203
• Study Type: observational
• Target: 1,534,706
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines

  case/no case study

  from the 01/01/2021 to the 26/01/2022

Study Arms (2)

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

Interventions

SARS-CoV-2 vaccine DRUG

SARS-CoV-2 vaccination

Patients presenting a malaise after the vaccination by any vaccine; Patients presenting any other adverse event after the vaccination by any vaccine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients

You may qualify if:

• all adverse events reported in the WHO pharmacovigilance database

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

Location

MeSH Terms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 10, 2022
• Study Start: January 1, 2021
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-04

Locations

FR (1)