| Trial registration number
|
EUCTR2021-000291-11-AT |
Full text link
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000291-11/AT
|
First author
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Medical University of Vienna - Selma Tobudic
|
Contact
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
selma.tobudic@meduniwien.ac.at
|
Registration date
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
2021-05-11
|
Recruitment status
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Recruiting
|
Study design
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
nonRCT
|
Allocation
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Non-randomized
|
Design
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Parallel
|
Masking
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Open label
|
Center
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
multi-center
|
Study aim
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Prevention
|
Inclusion criteria
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Male and female subjects will be eligible for participation in this study if they:
Are ≥18 years on the day of screening
Have a disease that is associated with a well characterized immunodeficiency (study population)
Treated with an immunosuppressive therapy (study population)
Have an immune-mediated disease without an immunosuppressive therapy, e.g. IBD patients solely with 5-ASA treatment (study population)
Are clinically healthy and not vaccinated with a SARS-CoV-2 vaccine (control group, age and sex-matched)
Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
|
Exclusion criteria
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Are not willing to get SARS-CoV-2 Vaccination
|
Number of arms
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
2
|
Funding
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Medical University of Vienna
|
Inclusion age min
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
18
|
Inclusion age max
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
100
|
Countries
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Austria
|
Type of patients
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
High risk patients
|
Severity scale
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
N/A
|
Total sample size
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
3000
|
primary outcome
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
To assess the humoral immunogenicity of the SARS-Cov-2 vaccination, the outcome of ELISA test and neutralization test will be analyzed one month after the second vaccination. Therefore, the number of subjects with positive seroconversion rate against SARS-CoV-2 will be evaluated.
|
Notes
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
nan
|
Phase
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
Phase 3
|
Arms
Last imported at : June 11, 2021, 1:30 a.m.
Source : EU Clinical Trials Register
|
[{"arm_notes": "100\u00b5g;2", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30\u00b5g;2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
|