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Risk of COVID-19 Infection After Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04848441
Recruitment Status : Not yet recruiting
First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Umeå University

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Vaccination; Infection Covid19 Other: The COVID-19 vaccines BNT162b2, mRNA-1273 and ChAdOx1

Study Design
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Study Type : Observational
Estimated Enrollment : 2000000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk of COVID-19 Infection After Vaccination: A Nationwide Study Comparing BNT162b2, mRNA-1273 and ChAdOx1
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: The COVID-19 vaccines BNT162b2, mRNA-1273 and ChAdOx1
    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.

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   0 Years to 110 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04848441


Contacts
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Contact: Peter Nordström, Prof +46907851000 peter.nordstrom@umu.se
Contact: Marcel Ballin, PhD marcel.ballin@umu.se

Sponsors and Collaborators
Umeå University
More Information
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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT04848441    
Other Study ID Numbers: VACC-COV-19
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umeå University:
COVID-19
Vaccination
Nationwide observational study
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases