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Trial - EUCTR2021-000893-27-BE


Column Value
Trial registration number EUCTR2021-000893-27-BE
Full text link
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

First author
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

AZ SInt-Jan Brugge-Oostende AV - Clinical Trial Center

Contact
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

ctc@azsintjan.be

Registration date
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

2021-03-04

Recruitment status
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

Recruiting

Study design
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

nonRCT

Allocation
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

Non-randomized

Design
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

Single group assignment

Masking
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

- health care employees (or patients) - 18 years or older - voluntarily receiving vaccination - pregnant or lactating

Exclusion criteria
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

- not eligible according to the inclusion criteria

Number of arms
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

1

Funding
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

AZ Sint-Jan Brugge-Oostende AV

Inclusion age min
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

Belgium

Type of patients
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

Health workers

Severity scale
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

15

primary outcome
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

presence and amount of IGM and IgG or IgA antibodies

Notes
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

Declared number of arm (1.0) differs from found arms (2.0)

Phase
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : April 28, 2021, 3:52 p.m.
Source : EU Clinical Trials Register

[{"arm_notes": "2;pregnant or lactating", "treatment_id": 339, "treatment_name": "Covid-19 mrna vaccine (nucleoside-modified)", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]