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NCT04928911 Clinical Trial

Expectations About the COVID-19 Vaccines

Vaccine Adverse Reaction Clinical Trial

Official title:
Expectations About the COVID-19 Vaccines

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04928911
Other study ID # AUvac
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 11, 2021
Est. completion date March 31, 2023

Study information
Verified date December 2023
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study collects information on expectations and attitudes towards the COVID-19 vaccines in participants about to receive a COVID-19 vaccine. This information will be linked to data on side effect occurrence collected in an independent study.

Description:

General hypothesis: Negative expectations and attitudes towards the vaccine are associated with a higher risk of side effects

Recruitment information / eligibility
Status Completed
Enrollment 1176
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Must have signed up to receive a COVID-19 vaccine in Denmark - Participants are also a part of the ENFORCE study from which outcome data is obtained - Must be able to read and understand Danish

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• COVID-19 vaccine
Adults about to receive a COVID-19 vaccine fill out a questionnaire of potential predictors of side effect occurrence

Locations
Country Name City State
Denmark Aarhus University Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of local and systemic reactions (self-report) Data obtained from independent study 7 days after vaccination
Primary Rate of local and systemic reactions (self-report) Data obtained from independent study 14 days after vaccination
Secondary Grade 1-4 and serious adverse events Data obtained from independent study 3-6 months after vaccination
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