Vaccination against COVID-19.
Conditions
Interventions
Trade Name: Comirnaty
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: modified mRNA, encoding full length SARS-CoV-2 spike protein
CAS Number: 2417899-77-3
Other descr
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Study participant who agreed to be included in the study "Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County". • Study participant who has received or will receive vaccine against Covid-19 and who gives new written consent to the study “Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County, with regard to on vaccinations”. 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 9500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: • those who have not given informed consent to participate in the study In this study, no initiative is taken for vaccination. The vaccinations are carried out by the healthcare system and of course follow the established exclusion and inclusion criteria for the approved vaccines, the package leaflets of which are attached. All persons who have received the vaccine and who give written consent are eligible to be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the incidence of SARS-CoV-2 infections after vaccination, to monitor the development of SARS-CoV-2 antibody levels after vaccination and to compare this in relation to both previous health & disease, previous antibody responses and in relation to future disease occurring after vaccination. ;Secondary Objective: Not applicable.;Primary end point(s): The primary endpoint is the detection of SARS-CoV-2 infection, relative to whether vaccination has been given. SARS-CoV-2 infections will be characterized by whether they are asymptomatic infections or sick leave-requiring infections. Regarding possible side effects, the primary outcome measure is sick leave, which will be characterized regarding every known case of illness within the cohort. ;Timepoint(s) of evaluation of this end point: 24 months post primary vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint is induction of antibodies to SARS-CoV-2. These will be characterized in terms of antibody levels, which SARS-CoV-2 antigen to which the response is directed and whether the antibodies are protective or not.;Timepoint(s) of evaluation of this end point: 24 months post primary vaccination. | — |
Countries
Sweden
Contacts
Public ContactJoakim Dillner
Karolinska University Hospital
Outcome results
None listed