Clinical Trials Logo
  1. Home
  2. Vaccine Adverse Reaction
  3. NCT05234333
  4. Details
NCT05234333 Clinical Trial

COVID-19 Vaccines Associated Malaise

Vaccine Adverse Reaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05234333
Other study ID # Pharmaco 20220203
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 26, 2022

Study information
Verified date April 2022
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 1534706
Est. completion date January 26, 2022
Est. primary completion date January 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - all adverse events reported in the WHO pharmacovigilance database Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SARS-CoV-2 vaccine
SARS-CoV-2 vaccination

Locations
Country Name City State
France Caen University Hospital, Department of Pharmacology Caen Normandie

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03966391 - Effectiveness of CARD for Improving School-Based Immunizations N/A
Completed NCT04530357 - Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine Phase 1/Phase 2
Terminated NCT03966300 - Improving the School Vaccination Experience: What CARDs Are You Going to Play? N/A
Active, not recruiting NCT06286488 - Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza Phase 4
Recruiting NCT05546502 - Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Phase 3
Active, not recruiting NCT05483725 - Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.
Completed NCT03600428 - Safety of LAIV4 in Children With Asthma Phase 4
Completed NCT03400878 - Comparing Morbidity and Mortality Effects of Two Different Strains of BCG Phase 4
Completed NCT05116748 - COVID19 Vaccine in SOT Adult Recipients
Not yet recruiting NCT05171946 - Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults Phase 1
Recruiting NCT05128721 - Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19) Phase 1
Withdrawn NCT04894682 - Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor
Not yet recruiting NCT05387252 - Glucoside- and Rutinoside-rich Crude Material for Relieving Side Effects of COVID-19 Vaccines N/A
Active, not recruiting NCT04801667 - Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients Phase 4
Not yet recruiting NCT05283902 - Effectiveness, Immunogenicity and Safety of the Second Booster Dose of the Vaccine Against COVID-19 in the Elderly
Recruiting NCT05095844 - National Vaccine Adverse Event Reporting Survey and Etiology
Recruiting NCT05315856 - Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms
Recruiting NCT05898464 - Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV Phase 4
Recruiting NCT05212792 - Genomics and COVID-19 Vaccine Adverse Events
Recruiting NCT05258708 - COVID-19 Vaccine Reactogenicity and Immunogenicity