We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date April 14, 2021
First Posted Date April 19, 2021
Last Update Posted Date April 19, 2021
Estimated Study Start Date May 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2021)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk of COVID-19 Infection After Vaccination
Official Title Risk of COVID-19 Infection After Vaccination: A Nationwide Study Comparing BNT162b2, mRNA-1273 and ChAdOx1
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Vaccination; Infection
  • Covid19
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 16, 2021)
2000000
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 0 Years to 110 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Peter Nordström, Prof +46907851000 peter.nordstrom@umu.se
Contact: Marcel Ballin, PhD marcel.ballin@umu.se
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04848441
Other Study ID Numbers VACC-COV-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Umeå University
Original Responsible Party Same as current
Current Study Sponsor Umeå University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Umeå University
Verification Date April 2021