| Trial registration number
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NCT04932824 |
Full text link
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04932824
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First author
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov
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Lara Hatchuel
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Contact
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov
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lhatchuel@linear.org.au
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Registration date
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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2021-06-21
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Recruitment status
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Crossover
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Masking
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- all subjects from study clo-scb-2019-001 will automatically move on to this long-term
follow-up study if: 1) they have given informed consent for this follow-up study; and
2) they have completed the d184 visit of study clo-scb-2019-001 (ie, 6 months post the
1 st vaccination).
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Exclusion criteria
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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- all subjects who did not participate and completed the study or did not signed the
inform consent for this follow up study.
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Number of arms
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Clover Biopharmaceuticals AUS Pty Ltd
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Inclusion age min
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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75
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Countries
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Australia
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Type of patients
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov
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137
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primary outcome
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov
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Incidence of AESIs and SAEs;Incidence of AESIs and SAEs;Serum anti-SCB-2019 IgG antibody titers;Serum anti-SCB-2019 IgG antibody titers
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Notes
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Phase 1
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Arms
Last imported at : Feb. 12, 2022, 3:30 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "2;Days0-21", "treatment_id": 1173, "treatment_name": "Scb-2019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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