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| Column | Value |
|---|---|
| Trial registration number | NCT04961502 |
|
Full text link
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
isabelle.dufour@gerondif.org |
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Registration date
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
2021-07-14 |
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Recruitment status
Last imported at : June 5, 2023, 8 a.m. Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 15, 2021, 6 a.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 : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
inclusion criteria for patients: person aged 75 and over, hospitalized in a long-term care unit participating in the study, having agreed to be vaccinated with the bnt162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities, not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study, having given their written consent to participate in the study, or having not expressed their opposition to participating and whose legal guardian has given their consent. inclusion criteria for younger adults (priority care staff): staff who have agreed to be vaccinated with the bnt162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities, not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study, having given their written consent to participate in the study. |
|
Exclusion criteria
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
None |
|
Number of arms
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Gérond'if |
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Inclusion age min
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
France |
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Type of patients
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
80 |
|
primary outcome
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott) |
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Notes
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Elderly", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Younger adults (priority caregivers)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |