ClinicalTrials.gov

History of Changes for Study: NCT04848441
Risk of COVID-19 Infection After Vaccination
Latest version (submitted April 16, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 16, 2021 None (earliest Version on record)
Comparison Format:

Scroll up to access the controls

Study NCT04848441
Submitted Date:  April 16, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: VACC-COV-19
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2021
Overall Status: Not yet recruiting
Study Start: May 1, 2021
Primary Completion: August 1, 2021 [Anticipated]
Study Completion: August 1, 2021 [Anticipated]
First Submitted: April 14, 2021
First Submitted that
Met QC Criteria:
April 16, 2021
First Posted: April 19, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
April 16, 2021
Last Update Posted: April 19, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Umeå University
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Vaccination; Infection
Covid19
Keywords: COVID-19
Vaccination
Nationwide observational study
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Retrospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 2000000 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 0 Years
Maximum Age: 110 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Peter Nordström, Prof
Telephone: +46907851000
Email: peter.nordstrom@umu.se
Central Contact Backup: Marcel Ballin, PhD
Email: marcel.ballin@umu.se
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services