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| Column | Value |
|---|---|
| Trial registration number | NCT05188677 |
|
Full text link
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : March 23, 2023, 4 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : March 23, 2023, 4 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
2022-01-12 |
|
Recruitment status
Last imported at : Aug. 26, 2023, 4 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 21, 2022, 9:30 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Sept. 1, 2022, 10 p.m. Source : ClinicalTrials.gov |
inclusion criteria: male and female participants at least 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 primary vaccination series with one of the selected covid-19 vaccines (comirnaty, vaxzevria, or coronavac) ≥3 months prior to enrollment; or received primary series and a booster dose (≥3 months after primary series) of coronavac, ≥3 months prior to enrollment. |
|
Exclusion criteria
Last imported at : Sept. 1, 2022, 10 p.m. Source : ClinicalTrials.gov |
individuals with fever >37.5°c (axillary), or any acute illness at baseline (day 1) or within 3 days prior to randomization; individuals with laboratory-confirmed sars-cov-2 infection at visit 1 (determined by positive rapid antigen test or rt-pcr); individuals who have received an investigational or licensed covid-19 vaccine prior to day 1 (except for primary series with comirnaty, vaxzevria, coronavac vaccines, or primary and booster dose of coronavac), or plan to receive covid-19 vaccine during the study period; individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines; individuals who have received any other investigational product within 30 days prior to day 1 or intend to participate in another clinical study at any time during the conduct of this study. |
|
Number of arms
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
11 |
|
Funding
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
Clover Biopharmaceuticals AUS Pty Ltd |
|
Inclusion age min
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : May 21, 2022, 9:30 a.m. Source : ClinicalTrials.gov |
Philippines |
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Type of patients
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 23, 2023, 4 p.m. Source : ClinicalTrials.gov |
1831 |
|
primary outcome
Last imported at : May 21, 2022, 9:30 a.m. Source : ClinicalTrials.gov |
GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15;GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15;GMT ratio of GMT SCB-2019 over GMT COVID-19 Vaccine Janssen on Day 15;Local and systemic solicited AEs reported within 7 days after study vaccination;SAEs, AEs leading to early termination from the study, MAAEs, and AESIs;Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29 |
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Notes
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Group 1a (primary series: Comirnaty)", "treatment_id": 1173, "treatment_name": "Scb-2019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 1b (primary series: Comirnaty)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 2a (primary series: Vaxzevria)", "treatment_id": 1173, "treatment_name": "Scb-2019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 2b (primary series: Vaxzevria)", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 3a (primary series: CoronaVac)", "treatment_id": 1173, "treatment_name": "Scb-2019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 3a (primary series: CoronaVac)", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 4a (primary series and booster dose CoronaVac)", "treatment_id": 1173, "treatment_name": "Scb-2019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 4b (primary series and booster dose CoronaVac)", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 4c (primary series and booster dose CoronaVac)", "treatment_id": 1173, "treatment_name": "Scb-2019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 5a (primary series: CoronaVac)", "treatment_id": 1173, "treatment_name": "Scb-2019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 5b (primary series: CoronaVac)", "treatment_id": 1173, "treatment_name": "Scb-2019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |