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| Column | Value |
|---|---|
| Trial registration number | NCT05303584 |
|
Full text link
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Aug. 17, 2022, 7 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Aug. 17, 2022, 7 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
2022-03-31 |
|
Recruitment status
Last imported at : Aug. 17, 2022, 7 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: health subjects aged ≥18 years 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. participants who have received three-dose of inactivated sars-cov-2 vaccine more than 6 months ago. |
|
Exclusion criteria
Last imported at : April 1, 2022, 3:30 p.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. vaccine-related sae occurred after previous vaccination with covid-19 vaccine. women with positive urine pregnancy test or in lactation. have acute febrile diseases or infectious diseases or have a history of sars. axillary temperature>37.0℃ have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmhg and/or diastolic blood pressure ≥110mmhg when measured in the field) have severe chronic diseases or condition is not stable, such as asthma, diabetes, thyroid disease congenital or acquired angioedema / neuroedema. have the history of urticaria 1 year before. have asplenia or functional asplenia. patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities. have history of sars-cov-2 infection or covid-19. have symptoms of upper respiratory tract infection. have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with sars-cov-2. any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent. |
|
Number of arms
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Jiangsu Province Centers for Disease Control and Prevention |
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Inclusion age min
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
360 |
|
primary outcome
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.;Incidence of adverse reactions within 28 days after the booster dose |
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Notes
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2066, "treatment_name": "Ad5-ncov-ih", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "IM", "treatment_id": 2066, "treatment_name": "Ad5-ncov-ih", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |