Vaccine Adverse ReactionNCT04928911
Expectations About the COVID-19 Vaccines
An observational study of Vaccine Adverse Reaction, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Adverse Reaction
- What is being tested?
- COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 1,176 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Jun 2021to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults signed up to receive a COVID-19 vaccine in Denmark, who are also participating in the ENFORCE study
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
General hypothesis: Negative expectations and attitudes towards the vaccine are associated with a higher risk of side effects
- Conditions
- Vaccine Adverse Reaction
- Being tested
- COVID-19 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccineBiological
Adults about to receive a COVID-19 vaccine fill out a questionnaire of potential predictors of side effect occurrence
| Study group | Role | What they receive |
|---|---|---|
| Adults receiving COVID-19 vaccine | Adults about to receive a COVID-19 vaccine fill out a questionnaire of potential predictors of side effect occurrence Receives: Biological: COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of local and systemic reactions (self-report)
Data obtained from independent study
Measured: 7 days after vaccination
Rate of local and systemic reactions (self-report)
Data obtained from independent study
Measured: 14 days after vaccination
Secondary outcomes (1)
Grade 1-4 and serious adverse events
Data obtained from independent study
Measured: 3-6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start11 Jun 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lene Vase, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928911
- Sponsor's protocol ID
- AUvac
- Status last verified
- Dec 2023
- First submitted
- 14 Jun 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectations About the COVID-19 Vaccines
- ClinicalTrials.gov ID
- NCT04928911
- Acronym / sponsor ID
- AUvac
- Conditions
- Vaccine Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,176 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults receiving COVID-19 vaccine | – | Biological: COVID-19 vaccineAdults about to receive a COVID-19 vaccine fill out a questionnaire of potential predictors of side effect occurrence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults signed up to receive a COVID-19 vaccine in Denmark, who are also participating in the ENFORCE study
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccineAdults about to receive a COVID-19 vaccine fill out a questionnaire of potential predictors of side effect occurrence | Biological | Adults receiving COVID-19 vaccine |
Primary outcome
Rate of local and systemic reactions (self-report)
Time frame: 7 days after vaccination
Data obtained from independent study
Rate of local and systemic reactions (self-report)
Time frame: 14 days after vaccination
Data obtained from independent study
1 secondary outcome
Grade 1-4 and serious adverse events
Time frame: 3-6 months after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene Vase study chair
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Adverse Reaction, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of local and systemic reactions (self-report) (time frame: 7 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.