Vaccination; InfectionNCT04848441
Risk of COVID-19 Infection After Vaccination
An observational study of Vaccination; Infection and Covid19, run by Umeå University.
Trial summary
The purpose of this observational nationwide study is to evaluate the effects of three different COVID-19 vaccines for the outcome of different severities of incident COVID infection. Read more about this study
- Who is it for?
- Ages 0 to 110 years
- Conditions the study is for
- Vaccination; Infection, Covid19
- What is being tested?
- The COVID-19 vaccines BNT162b2, mRNA-1273 and ChAdOx1
- Type of treatment
- Vaccines
- How many people
- 2,000,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Aug 2021
- 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 0 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will contain all Swedish citizens vaccinated with BNT162b2, mRNA-1273 or ChAdOx1, all Swedish citizens diagnosed with COVID-19, and a control group matched 1:1 on birth year, sex and municipality to the first two groups.
Who may be able to join
- Living in Sweden and vaccinated with BNT162b2, mRNA-1273 or ChAdOx1
- All individuals with a previous COVID-19 infection
- Controls matched 1:1 to the groups above
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
Marcel Ballin, PhD contact
About this study
Official title: Risk of COVID-19 Infection After Vaccination: A Nationwide Study Comparing BNT162b2, mRNA-1273 and ChAdOx1
The purpose of this observational nationwide study is to evaluate the effects of three different COVID-19 vaccines for the outcome of different severities of incident COVID infection.
- Conditions
- Vaccination; Infection, Covid19
- Being tested
- The COVID-19 vaccines BNT162b2, mRNA-1273 and ChAdOx1
- Keywords
- COVID-19, Vaccination, Nationwide observational study
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The COVID-19 vaccines BNT162b2, mRNA-1273 and ChAdOx1Other
The purpose of the study is to compare the effects of BNT162b2, mRNA-1273 and ChAdOx1 with respect to incident COVID-19 infection of different severities.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident COVID-19 infection
Four different severities: Being diagnosed, hospitalized, ICU-care and death within 30 days of diagnosis
Measured: Up to six 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 posted19 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination; InfectionStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848441
- Sponsor's protocol ID
- VACC-COV-19
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 19 Apr 2021
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of COVID-19 Infection After Vaccination: A Nationwide Study Comparing BNT162b2, mRNA-1273 and ChAdOx1
- ClinicalTrials.gov ID
- NCT04848441
- Acronym / sponsor ID
- VACC-COV-19
- Conditions
- Vaccination; Infection, Covid19
- Keywords
- COVID-19, Vaccination, Nationwide observational study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000,000 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 19 Apr 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.
The purpose of this observational nationwide study is to evaluate the effects of three different COVID-19 vaccines for the outcome of different severities of incident COVID infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will contain all Swedish citizens vaccinated with BNT162b2, mRNA-1273 or ChAdOx1, all Swedish citizens diagnosed with COVID-19, and a control group matched 1:1 on birth year, sex and municipality to the first two groups.
Key inclusion criteria (3 listed)
- Living in Sweden and vaccinated with BNT162b2, mRNA-1273 or ChAdOx1
- All individuals with a previous COVID-19 infection
- Controls matched 1:1 to the groups above
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| The COVID-19 vaccines BNT162b2, mRNA-1273 and ChAdOx1The purpose of the study is to compare the effects of BNT162b2, mRNA-1273 and ChAdOx1 with respect to incident COVID-19 infection of different severities. | Other | – |
Primary outcome
Incident COVID-19 infection
Time frame: Up to six months after vaccination
Four different severities: Being diagnosed, hospitalized, ICU-care and death within 30 days of diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- 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.
Marcel Ballin, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination; Infection and Covid19, run by Umeå University.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Nordström, Prof (+46907851000, peter.nordstrom@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident COVID-19 infection (time frame: Up to six months after vaccination). 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 19 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.