Immunantwort und Infektion nach Impfdurchbrüchen nach zulassungskonformer Impfung mit Comirnaty (BNT162b2) gegen SARS-CoV-2 im Bezirk Schwaz
- Conditions
- SARS-CoV-2 infectionsMedDRA version: 20.0Level: LLTClassification code 10021433Term: ImmunizationSystem Organ Class: 100000004865Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2021-002030-16-AT
- Lead Sponsor
- Medizinische Universität Innsbruck, Institut für Virologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3340
1.Participant is = 18 years of age on the day of signing the ICF and provides written informed consent
or
participant is between 16 and 18 years of age and provides informed consent as well as his/her legal representative/custodial
2.Subject has been already vaccinated with Comirnaty (two doses), with the second dose having been administered within up to 6 weeks (35 days ± 7 days) before study inclusion
3.Subject understands and agrees to comply with study procedures
4.Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation
Are the trial subjects under 18? yes
Number of subjects for this age range: 340
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
1.Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to either prevent or treat COVID-19
2.Participant has a contraindication to blood draws (eg, bleeding disorders)
3.Has participated in an interventional clinical study within 30 days prior to study inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method