COVERS (COVID-Vaccination Efficiency Risk and Safety Study)
Phase 1
- Conditions
- Coronavirus disease 2019 (COVID-19)Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-000413-17-SE
- Lead Sponsor
- Region Skåne - Kliniska Studier Sverige, Forum Söder
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4000
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
Subjects below the age of 18 are excluded
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>• Immune response after the first dose<br>• Immune response after the second dose (for vaccines given with two doses)<br>• Difference in immune response between different vaccine types<br>• Immune response in subpopulations (e.g. elderly (70+) and gender)<br>• Immune response in those who have undergone covid-19 infection without developing antibodies<br>• 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 Outcome Measures
Name Time Method Secondary end point(s): Follow-ups of immunity and self-reported side effects<br>a) What proportion becomes immune after vaccination?<br>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.