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| Column | Value |
|---|---|
| Trial registration number | NCT05409261 |
|
Full text link
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
axel.levier@anrs.fr |
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Registration date
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
2022-06-08 |
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Recruitment status
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
inclusion criteria: age between 18 and 45 years old or 55 years and older be eligible to receive one of the study vaccines as part of the trial understand and agree to comply with study procedures (visits, telephone calls) agree not to participate in any other vaccine study during the time of the study give written informed consent prior to any examination performed as part of the trial |
|
Exclusion criteria
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
positive sars-cov-2 antigenic test positive sars-cov-2 polymerase chain reaction (pcr) results less than 48 hours old history of infection by sars-cov-2 confirmed by antigenic test or pcr within 3 months prior to inclusion symptoms compatible with infection to sars-cov-2: sick or febrile participants (body temperature ≥ 38.0°c) pregnant or breastfeeding woman known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv) infection) anti-coagulant treatment immunosuppressive treatment contraindication to the proposed vaccine (according to rcp) previously received at least one injection of a sars-cov-2 vaccine patient having received immunoglobulin or another blood product within 3 months prior to inclusion a history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the sars-cov-2 vaccine) any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study |
|
Number of arms
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
ANRS, Emerging Infectious Diseases |
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Inclusion age min
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Mali |
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Type of patients
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
400 |
|
primary outcome
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level |
|
Notes
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |