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| Column | Value |
|---|---|
| Trial registration number | NCT05104216 |
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Full text link
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
hanqinghe@cdc.zj.cn |
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Registration date
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
2021-11-02 |
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Recruitment status
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : Nov. 3, 2021, 1:30 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 |
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Study aim
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - subjects aged 60 and above with full capacity for civil conduct; - chronic bronchitis (or chronic obstructive pulmonary disease) diagnosed by a medical institution at level i or above; - body temperature < 37.3 ° c confirmed by clinical examination before enrollment ; - able and willing to complete the entire study plan during the study follow-up period; - have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol; - subjects participating in the past clinical trial have completed two doses of covid-19 vaccine and blood collection before and after immunization; |
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Exclusion criteria
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
- subjects were previously confirmed cases of covid-19 or asymptomatic infected persons; - being allergic to any component of vaccines (including excipients) ; - injection of non-specific immunoglobulin within 1 month before enrollment; - injection of live attenuated vaccines within 1 month and injection of other vaccines within 14 days before enrollment; - subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angioneurotic edema, dyspnea, etc.); - having uncontrolled epilepsy and other progressive neurological disorders and a history of guillain-barre syndrome; - having severe liver and kidney diseases, malignant tumors, acute diseases or acute episodes of chronic diseases; - have been diagnosed with congenital or acquired immunodeficiency, hiv infection, lymphoma, leukaemia or other autoimmune diseases; - have been diagnosed with thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection; - during an acute episode of chronic bronchitis/chronic obstructive pulmonary disease; - subjects who had vaccine-related adverse reactions after the second dose; - having high fever (axillary temperature ≥39.0℃) for three days after the second dose of inoculation, or severe allergic reaction; - having any adverse nervous system reaction after the second dose; - during the acute onset of a chronic disease, or the recovery of acute complications less than two weeks; - other reasons for exclusion considered by the investigator. |
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Number of arms
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
China National Biotec Group Company Limited |
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Inclusion age min
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
60 |
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Inclusion age max
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
High risk patients |
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Severity scale
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
400 |
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primary outcome
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
Neutralizing antibody level;Neutralizing antibody level;Neutralizing antibody level;Seroconversion rate |
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Notes
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : Nov. 3, 2021, 1:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "third dose;Elderly People With Chronic Bronchitis and COPD", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |