| Trial registration number
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PACTR202206754734018 |
Full text link
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19387
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First author
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Babatunde Lawal ;Obi Salalo;Adigwe
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Contact
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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tundesalako@hotmail.com; o.p.adigwe@gmail.com
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Registration date
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-01-14
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Recruitment status
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy based on medical examination/history at the inclusion
Age 18-65 years
Signed informed consent
Prepared to grant authorized persons access to the medical records
The volunteer is likely to comply with instructions
Non pregnant female above 18 years
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Exclusion criteria
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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On current treatment with investigational agents for prophylaxis of COVID-19.
Plan to travel outside Nigeria from enrolment through 28 days after the last vaccination
Participation in other clinical trials
Known hypersensitivity to any of the vaccine components
History of hypersensitivity or severe allergic reaction
Laboratory parameters outside of normal range considered clinically relevant
Pregnant woman
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Number of arms
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Nigeria Federal Ministry of health
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Inclusion age min
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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65
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Countries
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Nigeria
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Type of patients
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1812
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primary outcome
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Geometric Mean Fold Rise (GMFR) of = 2.5 within the range of 20% non-inferiority to the standard dose of anti-SARS-CoV-2 S antibody response 14days after immunization detected by ELISA termed as seroconversion.
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Notes
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "fractional dose", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "standard dose", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}]
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