Expectations About the COVID-19 Vaccines

Completed

• Conditions: Vaccine Adverse Reaction
• Interventions: Biological: COVID-19 vaccine

• Registration Number: NCT04928911
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2021-06-11
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-16
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-12
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1176

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults receiving COVID-19 vaccine	COVID-19 vaccine	Adults about to receive a COVID-19 vaccine fill out a questionnaire of potential predictors of side effect occurrence

Primary Outcome Measures

Name	Time	Method
Rate of local and systemic reactions (self-report)	14 days after vaccination	Data obtained from independent study

Secondary Outcome Measures

Name	Time	Method
Grade 1-4 and serious adverse events	3-6 months after vaccination	Data obtained from independent study

Trial Locations

Locations (1)

Aarhus University; 🇩🇰 Aarhus, Denmark