Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD
NCT ID: NCT05075057
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2021-10-08
2022-06-30
Brief Summary
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Detailed Description
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Blood samples were collected before the first dose, 28 days after the second dose, before the third dose, 28 days after the third dose and 6 months after the third dose, respectively.
Any local or systemic adverse events that occurred within 21/28 days after vaccination will be recorded.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Experimental Group
A total 400 subjects aged ≥60 years with chronic bronchitis and COPD receive three doses inactivated COVID-19 vaccine on Day 0, Day 21, Day 111, respectively.
Inactivated COVID-19 vaccine
three doses of inactivated COVID-19 vaccine
Interventions
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Inactivated COVID-19 vaccine
three doses of inactivated COVID-19 vaccine
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Subjects have history of vaccination against COVID-19;
* 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, angoneeurotic 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;
* Other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
* Subjects who had vaccine-related adverse reactions after the first dose;
* Having high fever (axillary temperature ≥39.0℃) for three days after the first dose of inoculation, or severe allergic reaction;
* Having any adverse nervous system reaction after the first 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.
60 Years
ALL
No
Sponsors
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Hubei Provincial Center for Disease Control and Prevention
OTHER
Wuhan Institute of Biological Products Co., Ltd
INDUSTRY
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Xianfeng Zhang
Role: PRINCIPAL_INVESTIGATOR
Hubei Provincial Center for Disease Control and Prevention
Locations
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Hubei Center for Disease Control and Prevention
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WIBP2021COPD
Identifier Type: -
Identifier Source: org_study_id