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| Column | Value |
|---|---|
| Trial registration number | NCT04896788 |
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Full text link
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
promo_interne_drci@chu-clermontferrand.fr |
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Registration date
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-21 |
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Recruitment status
Last imported at : May 26, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : May 25, 2021, 12:32 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 : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - adult person, man or woman, staff of the clermont-ferrand university hospital (medical or paramedical, medico-technical or administrative caregiver), having received the second dose of vaccine (or the single dose if the single-dose vaccination schedule) against covid- 19 3 months +/- 15 days before the inclusion visit, as part of the national vaccination campaign, regardless of the type of vaccine administered. - for the subgroup included before vaccination (study of the pre-vaccination cellular response): adult person, man or woman, staff of clermont-ferrand university hospital (medical or paramedical, medico-technical or administrative caregiver), receiving the 1st injection on the same day or in the 7 days before the inclusion visit, regardless of the type of vaccine administered - commitment to respect the schedule of visits provided for in the research protocol - able to give informed consent to participate in research - affiliation to a social security scheme |
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Exclusion criteria
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- pregnancy or breastfeeding in progress at inclusion, or planned during follow-up - person under guardianship, guardianship or legal protection - whether the vaccine received was experimental or not authorized - refusal of participation |
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Number of arms
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
University Hospital, Clermont-Ferrand |
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Inclusion age min
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
65 |
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Countries
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
France |
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Type of patients
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Health workers |
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Severity scale
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
300 |
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primary outcome
Last imported at : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
the blood level of anti-S1 / RBD antibodies;the blood level of anti-S1 / RBD antibodies;the blood level of anti-S1 / RBD antibodies;the blood level of anti-S1 / RBD antibodies |
|
Notes
Last imported at : May 25, 2021, 12:32 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 : May 25, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Monitoring of the immune response\nBlood sample at 3,6,12,18 and 24 months in order to assess the blood level of anti-S1 / RBD anticoprs", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |