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| Column | Value |
|---|---|
| Trial registration number | NCT04892459 |
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Full text link
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
jingxin42102209@126.com |
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Registration date
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-05-19 |
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Recruitment status
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : May 27, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - health subjects aged 18-59 years, who have been completed two-dose regimen of inactive sars-cov-2 vaccine in the past 3-6 months, or received one dose of inactive sars-cov-2 vaccine in the past 1-3 months. - the subject can provide with informed consent and sign informed consent form (icf). - the subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study. - axillary temperature ≤ 37.0℃. - individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization. |
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Exclusion criteria
Last imported at : May 27, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis. - be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination. - women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months. - have acute febrile diseases and infectious diseases. - have severe chronic diseases or condition in progress cannot be controlled. - congenital or acquired angioedema / neuroedema - have the history of urticaria 1 year before receiving the investigational vaccine. - have asplenia or functional asplenia. - have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection). - have needle sickness. - have the history of immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months. - have received blood products within 4 months before injection of investigational vaccines. - under anti-tuberculosis treatment. - not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social or other conditions. |
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Number of arms
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Jiangsu Province Centers for Disease Control and Prevention |
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Inclusion age min
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
59 |
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Countries
Last imported at : June 10, 2021, 12:33 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
300 |
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primary outcome
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.;Incidence of adverse reactions within 28 days after the booster dose. |
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Notes
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : May 21, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "2 doses of inactive SARS-CoV-2 vaccine + booster of recombinant SARS-CoV-2 Ad5 vectored vaccine after 3~6 months", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 dose of inactive SARS-CoV-2 vaccine + 1 dose of recombinant SARS-CoV-2 Ad5 vectored vaccine after 1~3 months", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2 doses of inactive SARS-CoV-2 vaccine + booster dose of inactive SARS-CoV-2 vaccine after 3~6 months", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 dose of inactive SARS-CoV-2 vaccine + 1 dose of inactive SARS-CoV-2 vaccine after 1~3 months.", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |