v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT05926440 |
|
Full text link
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
closcb2023002@cloverbiopharma.com |
|
Registration date
Last imported at : July 7, 2023, 4 a.m. Source : ClinicalTrials.gov |
2023-07-03 |
|
Recruitment status
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
inclusion criteria: male or female ≥18 years of age. individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures. individuals willing and able to give an informed consent, prior to screening. healthy participants or participants with pre-existing medical conditions who are in a stable medical condition. individuals who received three doses of inactivated covid-19 vaccine. |
|
Exclusion criteria
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
body temperature >37.8°c (axillary), or any acute illness at baseline. confirmed sars-cov-2 infectionor with known history of covid-19. individuals who have received an investigational or licensed covid-19 vaccine prior to day 1 (except for inactivated covid-19 vaccine). any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy. any progressive unstable or uncontrolled clinical conditions. individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period. history of severe adverse reaction associated with a vaccine or severe allergic reaction. history of malignancy within 1 year before screening. individuals who have received any other investigational product. individuals who have received any other licensed vaccines within 14 days prior to enrollment. treatment with rituximab or any other anti-cd20 monoclonal antibodies. known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection. administration of intravenous immunoglobulins and/or any blood products. any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant. |
|
Number of arms
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Clover Biopharmaceuticals AUS Pty Ltd |
|
Inclusion age min
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Philippines |
|
Type of patients
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
600 |
|
primary outcome
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine;Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine;Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine;To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5;To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5 |
|
Notes
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : July 4, 2023, 8 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1173, "treatment_name": "Scb-2019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2759, "treatment_name": "Scb-2023", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |