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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05047718 |
|
Full text link
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 6, 2022, 8 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Oct. 6, 2022, 8 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
2021-09-17 |
|
Recruitment status
Last imported at : April 19, 2023, noon Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
nonRCT |
|
Allocation
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - for the group with a past history of covid-19 (convalescents)= subject within ≥ 3 months after infection - for the no past history of covid-19 (naives), subject with no known history of covid-19 - patient affiliated or entitled to a social security plan - patients who have received informed information about the study and who have co-signed a consent to participate in the study with the investigator |
|
Exclusion criteria
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
- immunocompromised or under immunosuppressive treatment - subject with a history of covid hospitalized in intensive care - subject allergic to one of the components of the vaccines used in the study - subject vaccinated for covid-19 - subject with persistent symptoms of covid-19 (long covid) - subjects with unstable chronic pathology - persons deprived of liberty, hospitalized without consent - pregnant or breastfeeding woman |
|
Number of arms
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Centre Hospitalier Universitaire de Saint Etienne |
|
Inclusion age min
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
France |
|
Type of patients
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Oct. 6, 2022, 8 a.m. Source : ClinicalTrials.gov |
54 |
|
primary outcome
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Anti-S neutralizing antibody titer |
|
Notes
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Healthy volunteers;2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Infected patients;1", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Healthy volunteers;2", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Infected patients;1", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |