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| Name | Class |
|---|---|
| Guizhou Center for Disease Control and Prevention | OTHER |
| Hunan Provincial Center for Disease Control and Prevention | OTHER |
| Center for Disease Control and Prevention, Fujian | OTHER |
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To evaluate the post-marketing immunogenicity, safety and antibody persistence of the third dose (booster) of Covid-19 vaccine in patients aged 60 years or older with hypertension and/or diabetes.
After giving informed consent, patients with hypertension, patients with diabetes, patients with both diseases, and healthy controls, all aged 60 years or older, are given a third doses of the inactivated SARS-CoV-2 vaccine (Vero cells).
These subjects are all from the "COVAX (HT/DM)-Beijing" clinical trial (NCT05065879). 50% of them receive the booster vaccine 3 months after the second dose (0-1-4 schedule); 50% of them receive the booster vaccine 5 months after the second dose (0-1-6 schedule).
Venous blood samples are collected before the booster dose and on day 28 after the booster dose to evaluate the immunogenicity of the vaccine.
Venous blood samples are also collected on day 84/168/252/336 after the booster dose to evaluate the antibody persistence of the vaccine.
Adverse events are actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the booster dose. Serious adverse events (SAE) are collected within 6 months after the booster dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0-1-4 schedule group | Experimental | Subjects receive the booster vaccine 3 months after the second dose. |
|
| 0-1-6 schedule group | Experimental | Subjects receive the booster vaccine 5 months after the second dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covid-19 vaccine (0-1-4 schedule) | Biological | Subjects receive the booster vaccine 3 months after the second dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | the rate of positive seroconversion against coronavirus | Up to 28 days after the booster dose |
| Neutralizing antibody level | neutralizing antibody level against coronavirus | Up to 28 days after the booster dose |
| Neutralizing antibody level | neutralizing antibody level against coronavirus | Up to 84 days after the booster dose |
| Neutralizing antibody level | neutralizing antibody level against coronavirus | Up to 168 days after the booster dose |
| Neutralizing antibody level | neutralizing antibody level against coronavirus | Up to 252 days after the booster dose |
| Neutralizing antibody level | neutralizing antibody level against coronavirus | Up to 336 days after the booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events following vaccination | analyse the incidence of adverse events following immunization, both solicited and unsolicited | Up to 6 months after the booster dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FangJun LI | Contact | +86-13574109585 | ymlc05@hncdc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nan'an Center for Disease Control and Prevention | Quanzhou | Fujian | China | |||
| Yong'an Center for Disease Control and Prevention |
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| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
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Serum testing technicians will be masked.
| Covid-19 vaccine (0-1-6 schedule) | Biological | Subjects receive the booster vaccine 5 months after the second dose. |
|
| Sanming |
| Fujian |
| China |
| Youxi Center for Disease Control and Prevention | Sanming | Fujian | China |
| Songtao Miao Autonomous County Center for Disease Control and Prevention | Tongren | Guizhou | China |
| Linli County Center for Disease Control and Prevention | Changde | Hunan | China |
| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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