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| Column | Value |
|---|---|
| Trial registration number | NCT05148845 |
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Full text link
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
mayatf@phru.co.za |
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Registration date
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
2021-12-08 |
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Recruitment status
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : Dec. 10, 2021, 12:30 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. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria age 18 and older all sisonke participants received a priming ad26.sars.cov.2.s vaccination as part of the sisonke study at least 6 months prior participants who are pregnant or report breastfeeding at the time of enrolment may be included. willingness and ability to comply with vaccination plan and other study procedures. capable of giving electronic or personal signed informed consent as described in appendix 5, which includes compliance with the requirements in this protocol. |
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Exclusion criteria
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
participants who have received boosting vaccination through other means. any significant acute or chronic medical condition, situation or circumstance that in the opinion of the pi/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant current participation in any other research studies that would interfere with the objectives of this study. the determination of whether participation in another study would be exclusionary for a given participant will be made by the pi/designee. participants with a history of heparin-induced thrombocytopenia or tts |
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Number of arms
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
Wits Health Consortium (Pty) Ltd |
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Inclusion age min
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
South Africa |
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Type of patients
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
500000 |
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primary outcome
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
To assess the effectiveness of Ad26.COV2.S (Janssen) boost vaccine on severe COVID, hospitalizations and deaths in Sisonke participants as compared to unboosted Sisonke participants (single Ad26 vaccine only) |
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Notes
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
Declared number of arm (None) differs from found arms (1.0) |
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Phase
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Dec. 10, 2021, 12:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "1;Received a priming Ad26.SARS.COV.2.S vaccination at least 6 months prior", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |