COVERS (COVID-Vaccination Efficiency Risk and Safety Study)

COVERS (COVID-Vaccination Efficiency Risk and Safety Study) - an open trial for follow-up of efficacy, risk and safety in persons who have been vaccinated against SARS-CoV-2 in Region Skåne with vaccines approved in Sweden

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000413-17-SE

Enrollment

4000

Registered

2021-02-15

Start date

2021-02-24

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus disease 2019 (COVID-19)

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. To be included, the person must have received the COVID-19 vaccine. 2. To be included, the person must, in addition to vaccination against COVID-19, also have a) signed by EPM approved participant information b) reached the age of 18. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000

Exclusion criteria

Exclusion criteria: Subjects below the age of 18 are excluded

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparative effect over time on the immune response of approved COVID-19 vaccines used in mass vaccination in Sweden;Secondary Objective: • Immune response in people with a history of covid-19 infection. • Immune response after the first dose • Immune response after the second dose (for vaccines given with two doses) • Difference in immune response between different vaccine types • Immune response in subpopulations (e.g. elderly (70+) and gender) • Immune response in those who have undergone covid-19 infection without developing antibodies • Immune response over time;Primary end point(s): Serology against COVID-19;Timepoint(s) of evaluation of this end point: The serology against COVID-19 will be evaluated in conjunction to the vaccination and 1, 6, 12 och 24 monts after.	—

Measure

Time frame

Main Objective: Comparative effect over time on the immune response of approved COVID-19 vaccines used in mass vaccination in Sweden;Secondary Objective: • Immune response in people with a history of covid-19 infection. • Immune response after the first dose • Immune response after the second dose (for vaccines given with two doses) • Difference in immune response between different vaccine types • Immune response in subpopulations (e.g. elderly (70+) and gender) • Immune response in those who have undergone covid-19 infection without developing antibodies • Immune response over time;Primary end point(s): Serology against COVID-19;Timepoint(s) of evaluation of this end point: The serology against COVID-19 will be evaluated in conjunction to the vaccination and 1, 6, 12 och 24 monts after.

—

Secondary

Measure	Time frame
Secondary end point(s): Follow-ups of immunity and self-reported side effects a) What proportion becomes immune after vaccination? b) How long does antibody-mediated, cellular and local immunity remain after vaccination?;Timepoint(s) of evaluation of this end point: The serology against COVID-19 will be evaluated in conjunction to the vaccination and 1, 6, 12 och 24 monts after.	—

Countries

Sweden

Contacts

Public ContactUlf Malmqvist

Kliniska Studier Sverige, Forum Söder

ulf.malmqvist@skane.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026