NCT04848441

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 14, 2021

Last Update Submit

April 16, 2021

Conditions

Vaccination; InfectionCovid19

Keywords

COVID-19VaccinationNationwide observational study

Outcome Measures

Primary Outcomes (1)

  • Incident COVID-19 infection

    Four different severities: Being diagnosed, hospitalized, ICU-care and death within 30 days of diagnosis

    Up to six months after vaccination

Interventions

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.

Eligibility Criteria

Age0 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InfectionsCOVID-19

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA VaccinesNucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral VaccinesAntigensBiological Factors

Central Study Contacts

Peter Nordström, Prof

CONTACT

+46907851000peter.nordstrom@umu.se

Marcel Ballin, PhD

CONTACT

marcel.ballin@umu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 19, 2021

Study Start

May 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share