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| Column | Value |
|---|---|
| Trial registration number | NCT04984408 |
|
Full text link
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
fmarks@ivi.int |
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Registration date
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
2021-07-30 |
|
Recruitment status
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
unclear |
|
Study aim
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - female and male adults aged 18 years and older (arm 1-group 1 and arm 2-group 1) and 18-65 years (arm 1 - group 2, arm 2-group 2 and arm3-group1) at the time of consent. - residing within the beira and maputo health region and planning to stay for the study duration. - hiv-negative test result at the day of screening for participants in group 1, in arms 1, 2 and 3 - hiv-positive and on anti-retroviral treatment for at least six months for participants in group 2, in arms 1 and 2 - female volunteers of childbearing potential with a negative pregnancy test on the day(s) of screening and vaccination, practicing/willing to practice continuous effective contraception recommended by the national health system up to four weeks after the third vaccination. - able and willing to comply with all study requirements, based on the assessment of the investigator. - provide written informed consent before any trial procedure. |
|
Exclusion criteria
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
- pregnant, lactating, or with intention to become pregnant during the study. - planned receipt of any investigational vaccine than the study intervention within 28 days before and after each study vaccination. - active covid-19 infection at the time of enrollment - history of allergic reactions or anaphylaxis to previous immunization or allergies to any components of the vaccines. - history of bleeding disorder, or prior history of significant bleeding or bruising following intramuscular injections or venipuncture (for the immunogenicity subset and hiv infected participants). - any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor quality data. |
|
Number of arms
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
International Vaccine Institute |
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Inclusion age min
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
8825 |
|
primary outcome
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Protection conferred by BBIBP-CorV vaccine against any COVID-19 disease |
|
Notes
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : July 31, 2021, 1 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 521, "treatment_name": "Flu vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 1831, "treatment_name": "Bbibp-corv+flu vaccine", "treatment_type": "Inactivated virus+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}] |