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Trial - EUCTR2021-000349-42-SE


Column Value
Trial registration number EUCTR2021-000349-42-SE
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/2021-000349-42/SE

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

Not reported

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

Not reported

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

2021-02-08

Recruitment status
Last imported at : Jan. 5, 2025, 10:55 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

1. All participants must give written informed consent 2. Woman or man aged 18 years or older

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

1. Inability to give written informed consent 2. Inability to undergo blood sampling, e.g. due to lack of suitable blood vessels for sampling

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

1

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

Sahlgrenska Academy, University of Gothenburg

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

100

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

Sweden

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

500

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

Immune responses following vaccination for COVID-19 as measured by: 1. a novel rapid spike interferon-gamma release assay 2. a novel rapid spike activation-induced marker assay 3. anti-spike IgG serology

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

nan

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": "2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]