| Trial registration number
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EUCTR2021-000633-14-CZ |
Full text link
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000633-14/CZ
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First author
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Státní zdravotní ústav - Radomíra Limberková
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Contact
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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radomira.limberkova@szu.cz
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Registration date
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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2021-02-18
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Recruitment status
Last imported at : June 18, 2024, 4:14 a.m.
Source : EU Clinical Trials Register
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Completed
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Study design
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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nonRCT
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Allocation
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Non-randomized
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Design
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Parallel
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Masking
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Open label
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Center
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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single-center
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Study aim
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Prevention
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Inclusion criteria
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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those who were vaccinated in the vaccination centre of Státní zdravotní ústav and singed informed consent with participation in the study
ti, kteří byli očkováni v očkovacím středisku Státního zdravotního ústavu a informovaným souhlasem potvrdili účast ve studii
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Exclusion criteria
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
|
contraindications of vaccine application according to Summary of product characteristics
application of the first dose of the vaccine after the 1st of February 2021
kontraindikace očkování, tak jak jsou uvedeny v Souhrnu údajů o přípravku
aplikace 1.dávky vakcíny po 1.únoru 2021
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Number of arms
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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1
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Funding
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Státní zdravotní ústav
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Inclusion age min
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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18
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Inclusion age max
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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100
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Countries
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Czech Republic
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Type of patients
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Healthy volunteers
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Severity scale
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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N/A
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Total sample size
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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300
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primary outcome
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Discontinuation of the treatment for adverse events
individual decision not to continue in the study anytime
Vysazení léčby z bezpečnostních důvodů
Individuální rozhodnutí nepokračovat ve studii kdykoliv v průběhu studie
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Notes
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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nan
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Phase
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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Phase 4
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Arms
Last imported at : June 30, 2021, 6:30 a.m.
Source : EU Clinical Trials Register
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[{"arm_notes": "2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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