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| Name | Class |
|---|---|
| Zhejiang Provincial Center for Disease Control and Prevention | OTHER_GOV |
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
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Evaluation of immunogenicity, safety and persistence of the subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease received the third dose of inactivated COVID-19 vaccine .
The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease recruited to receive a third dose of inactivated COVID-19 vaccine.
Blood samples will be collected 3 times: before the third dose of vaccinatioin,28 days and 6 months after the third dose of vaccination.
Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Subjects receive a third dose of inactivated COVID-19 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated COVID-19 vaccine | Biological | receive a third dose of inactivated COVID-19 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | The rate of seroconversion against coronavirus | 28 days after the 3th dose (Day 28) |
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus before the 3th dose | Before the 3th dose (Day 0) |
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 28 days after the 3th dose (Day 28) |
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 6 months after the 3th dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events rate | Analyse the incidence of adverse events following vaccination, both solicited and unsolicited | 0-21days following vaccinations |
| Serious adverse event rate | Report and analyse serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanqing He | Contact | (0571)87115111 | hanqinghe@cdc.zj.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hanqing He | Zhejiang Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang provincial center for disease control and prevention | Hangzhou | Zhejiang | 310051 | China |
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Subjects aged ≥60 with chronic bronchitis and COPD who have completed the schedule of two doses for 3 months receive a third dose of inactivated COVID-19 vaccine.
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| 0-6 months |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D029481 | Bronchitis, Chronic |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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