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| Column | Value |
|---|---|
| Trial registration number | EUCTR2021-000566-14-CZ |
|
Full text link
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000566-14/CZ |
|
First author
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
|
|
Contact
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
demlova@med.muni.cz |
|
Registration date
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
2021-02-17 |
|
Recruitment status
Last imported at : Jan. 27, 2024, 12:13 p.m. Source : EU Clinical Trials Register |
Completed |
|
Study design
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
nonRCT |
|
Allocation
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Non-randomized |
|
Design
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Single group assignment |
|
Masking
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Open label |
|
Center
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
multi-center |
|
Study aim
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Prevention |
|
Inclusion criteria
Last imported at : Sept. 18, 2023, 2:45 p.m. Source : EU Clinical Trials Register |
1) Age ≥ 18 years 2) Willingness to participate in the study expressed by signing the informed consent form A subject can be included in a cohort of newly enrolled subjects with an already fully applied vaccination scheme according to SmPC, if they additionally meet the following criteria: 1) Patient in the care of the Department of Internal Hematology and Oncology, University Hospital Brno 2) Planned booster dose (3rd dose for the originally two-dose schedule, or 2nd dose for the single-dose schedule) 1) Věk ≥ 18 let 2) Ochota účastnit se studie vyjádřená podpisem formuláře informovaného souhlasu Subjekt může být zařazen do kohorty nově zařazených subjektů s již plně aplikovaným očkovacím schématem dle SmPC, pokud navíc splňuje následující kritéria: 1) Pacient v péči Interní hematologické a onkologické kliniky Fakultní nemocnice Brno 2) Plánované přeočkování booster dávkou (3. dávka u původně dvoudávkového schématu, příp. 2. dávka u jednodávkového schématu) |
|
Exclusion criteria
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
1) Pregnancy, breastfeeding 2) Inadequacy of patient classification based on the individual assessment of the study physician 1) Těhotenství, kojení 2) Nevhodnost zařazení pacienta na základě individuálního posouzení zkoušejícího lékaře |
|
Number of arms
Last imported at : Nov. 2, 2021, 4:30 p.m. Source : EU Clinical Trials Register |
4 |
|
Funding
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Masarykova univerzita |
|
Inclusion age min
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
18 |
|
Inclusion age max
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
100 |
|
Countries
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Czech Republic |
|
Type of patients
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Healthy volunteers |
|
Severity scale
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
N/A |
|
Total sample size
Last imported at : Sept. 18, 2023, 2:45 p.m. Source : EU Clinical Trials Register |
565 |
|
primary outcome
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
1) monitoring for adverse events and effects 2) evaluation of the immune response of vaccinated subjects 3) incidence of COVID-19 disease in vaccinated subjects 1) sledování nežádoucích příhod a účinků 2) hodnocení imunitní odpovědi vakcinovaných subjektů 3) incidence onemocnění COVID-19 u vakcinovaných subjektů |
|
Notes
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
nan |
|
Phase
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Phase 4 |
|
Arms
Last imported at : Nov. 2, 2021, 4:30 p.m. Source : EU Clinical Trials Register |
[{"arm_notes": "2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |