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Trial - EUCTR2021-000182-33-NL


Column Value
Trial registration number EUCTR2021-000182-33-NL
Full text link
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000182-33/NL

First author
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Radboudumc - Konstantin Föhse

Contact
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

konstantin.fohse@radboudumc.nl

Registration date
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

2021-01-21

Recruitment status
Last imported at : Jan. 21, 2023, 12:23 p.m.
Source : EU Clinical Trials Register

Completed

Study design
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

nonRCT

Allocation
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Non-randomized

Design
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

- Age equal to or above 18 years, - Written informed consent provided by the participant, - Receiving BioNTech/Pfizer COVID-19 vaccine per routine care, - Having received BCG-vaccination in the past 12 months OR never having received BCG-vaccination. - Leeftijd ouder dan of gelijk aan 18 jaar. - Schriftelijke toestemming voor deelname, - Wordt via de reguliere zorg met het BioNTech/Pfizer COVID-19 vaccin gevaccineerd, - In de afgelopen 12 maanden gevaccineerd met BCG OF nooit een BCG vaccinatie gehad.

Exclusion criteria
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

- Legally incapacitated or unwilling to provide informed consent, - History of COVID-19 infection, confirmed by a microbiological test. - Juridisch handelingsonbekwaam of geen schriftelijke toestemming willen geven, - Doorgemaakte COVID-19 infectie, bewezen met een microbiologische test.

Number of arms
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Radboudumc

Inclusion age min
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

65

Countries
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Netherlands

Type of patients
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Healthy volunteers

Severity scale
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

40

primary outcome
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Seroconversion of IgG to the SARS-CoV-2 spike protein at day 21 after the first dose of Pfizer/BioNTech BNT162B2. Seroconversion of antibodies is defined as a change from seronegative at baseline (pre-1st dose of Pfizer/BioNTech BNT162B2) to seropositive or a ≥four-fold titer increase if the participant is seropositive at baseline Seroconversie van IgG naar SARS-CoV-2 spike eiwit op dag 21 na de eerste injectie van het Pfizer/BioNTech BNT162B2 vaccin. Seroconversie van de antilichamen is gedefineerd als verandering van seronegatief bij aanvang/baseline (vóór de eerste injectie van het Pfizer/BioNTech BNT162B2 vaccin) naar seropositief of een viervoud verhoogde stijging van titer als de deelnemer bij aanvang/baseline seropositief was.

Notes
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

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

Phase
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : March 27, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "1; prior received BCG vaccination", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1; never received BCG vaccination", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]