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Trial - EUCTR2020-006003-42-DK


Column Value
Trial registration number EUCTR2020-006003-42-DK
Full text link
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006003-42/DK

First author
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

CHIP - Rigshospitalet, University of Copenhagen - Jens Lundgren

Contact
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

jens.lundgren@regionh.dk

Registration date
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

2020-12-21

Recruitment status
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Recruiting

Study design
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

nonRCT

Allocation
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Non-randomized

Design
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

multi-center

Study aim
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

1. Written informed consent obtained before any trial related procedures are performed 2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan) 3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)

Exclusion criteria
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

1. Male and female under the age of 18 2. Any subgroup of individuals for which the vaccines are contra-indicated 3. Previous SARS-CoV-2 vaccination

Number of arms
Last imported at : Feb. 16, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

4

Funding
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

CHIP - Rigshospitalet - University of Copenhagen

Inclusion age min
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Denmark

Type of patients
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Healthy volunteers

Severity scale
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

10000

primary outcome
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Primary outcome is the minimal protective neutralising antibody titre (MPNAT), i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected.

Notes
Last imported at : Feb. 16, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Declared number of arm (4.0) differs from found arms (1.0)

Phase
Last imported at : Jan. 5, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : Feb. 16, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "SARS-CoV2 vaccines being applied in the Danish COVID-19 vaccine programme, population includes also a group of high risk patients.", "treatment_id": 1153, "treatment_name": "Sars-cov-2 mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SARS-CoV2 vaccines being applied in the Danish COVID-19 vaccine programme, population includes also a group of high risk patients.", "treatment_id": 1153, "treatment_name": "Sars-cov-2 mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SARS-CoV2 vaccines being applied in the Danish COVID-19 vaccine programme, population includes also a group of high risk patients.", "treatment_id": 1153, "treatment_name": "Sars-cov-2 mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SARS-CoV2 vaccines being applied in the Danish COVID-19 vaccine programme, population includes also a group of high risk patients.", "treatment_id": 1153, "treatment_name": "Sars-cov-2 mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]