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| Column | Value |
|---|---|
| Trial registration number | NCT05157178 |
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Full text link
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
2021-12-14 |
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Recruitment status
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
inclusion criteria: availability to participate during the entire study, and ability to follow study protocol strictly. consent to supply personal contact information, such as telephone numbers, address and other information so the research team may contact the participant (for example, in case the participant fails to attend a scheduled visit without previous notice) ability to understand and sign the volunteered and informed consent form, and ability to fill in the adverse events journal at home, according to the evaluation of the principal investigator ou delegated research team members. understanding the impossibility of participating in another clinical trial while participating in this clinical trial. ability to fill out the adverse events journal at home |
|
Exclusion criteria
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
pregnancy or puerperium having received any other covid-19 vaccine any time before inclusion in the study having received any other vaccine 30 days before inclusion in the study covid-19 disease confirmed by rt-pcr (real time polymerase chain reaction) up to 28 days before inclusion in the study. covid-19 symptoms during evaluation of inclusion in the study (day 0). fever (axillary temperature above 37,8 º c / 100,04 °f) 72 hours before vaccination in the study. contraindications to the covid-19 (recombinante) vaccine - fiocruz/astrazeneca use of immunosuppressive medication, such as systemic corticosteroids or chemotherapy, or immunosuppressive diseases. we will consider as immunosuppressive doses of systemic corticosteroids daily doses of prednisone of 10mg or more, for more than 14 days. any discoveries made by the principal investigator that would enhance the risk of an adverse result following the participation in the study, or that in some other way justifies exclusion from the study. |
|
Number of arms
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) |
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Inclusion age min
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Brazil |
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Type of patients
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
1264 |
|
primary outcome
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Geometric mean titers of IgG Anti-S antibody after two doses of Covid-19 (recombinante) |
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Notes
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : Dec. 16, 2021, 2 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "2;4 weeks interval", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;8 weeks interval", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;12 weeks interval", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |