Expectations About the COVID-19 Vaccines

January 17, 2024 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults signed up to receive a COVID-19 vaccine in Denmark, who are also participating in the ENFORCE study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults receiving COVID-19 vaccine
Adults about to receive a COVID-19 vaccine fill out a questionnaire of potential predictors of side effect occurrence
Biological: COVID-19 vaccine
Adults about to receive a COVID-19 vaccine fill out a questionnaire of potential predictors of side effect occurrence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of local and systemic reactions (self-report)
Time Frame: 7 days after vaccination
Data obtained from independent study
7 days after vaccination
Rate of local and systemic reactions (self-report)
Time Frame: 14 days after vaccination
Data obtained from independent study
14 days after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade 1-4 and serious adverse events
Time Frame: 3-6 months after vaccination
Data obtained from independent study
3-6 months after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Lene Vase, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • AUvac

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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