NCT04928911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,176

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

January 18, 2024

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

June 14, 2021

Last Update Submit

January 17, 2024

Conditions

Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (2)

  • Rate of local and systemic reactions (self-report)

    Data obtained from independent study

    7 days after vaccination

  • Rate of local and systemic reactions (self-report)

    Data obtained from independent study

    14 days after vaccination

Secondary Outcomes (1)

  • Grade 1-4 and serious adverse events

    3-6 months after vaccination

Study Arms (1)

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

Interventions

COVID-19 vaccineBIOLOGICAL

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

Adults receiving COVID-19 vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, Denmark

Location

MeSH Terms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Lene Vase

    University of Aarhus

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 16, 2021

Study Start

June 11, 2021

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

January 18, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)