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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05583357 |
|
Full text link
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
2022-10-17 |
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Recruitment status
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Crossover |
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Masking
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
inclusion criteria: adults aged 18 years and older at time of consent, male or female; normal body temperature; meet either of the following conditions: received completed primary immunization of 2 doses of coronavac 6-15 months ago; received completed 3 doses of coronavac 5-9 months ago; female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment; be able and willing to complete the study during the entire study and follow-up period; participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol. |
|
Exclusion criteria
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
serious chronic diseases or uncontrolled diseases; uncontrolled neurological disorders, epilepsy; received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks; patients with congenital or acquired immunodeficiency; history of severe allergy or be allergic to any components of the test vaccines; history of hereditary hemorrhagic tendency or coagulation dysfunction; patients with malignant tumors and other patients have a life expectancy less than 1 year; refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol; history of previous covid-19 infection; pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study; participants who have participated in other clinical trials within 3 months or are participating in other clinical trials; those considered by the investigator as inappropriate to participate in the study. |
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Number of arms
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Livzon Pharmaceutical Group Inc. |
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Inclusion age min
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
40 |
|
primary outcome
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Neutralizing antibody GMT of Omicron BA.5 |
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Notes
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : Oct. 18, 2022, 12:35 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago", "treatment_id": 2627, "treatment_name": "V-01d-351", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago", "treatment_id": 2627, "treatment_name": "V-01d-351", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |