COVID-19 Pneumonia Clinical Trial
Official title:
A Post-marketing Clinical Study of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Beijing): Immunogenicity and Safety Assessments in Patients With Hypertension and/or Diabetes
Verified date | January 2022 |
Source | China National Biotec Group Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations.
Status | Completed |
Enrollment | 1440 |
Est. completion date | January 5, 2022 |
Est. primary completion date | January 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - =60 years old individuals with full civil capacity. - Clinically confirmed body temperature of <37.3°C before enrolling in this study. - Able and willing to participate in the study plan during the entire study and follow-up period. - Capable of understanding the study procedures, willing to sign the informed consent form, and able to comply with the requirements of the clinical study protocol. - Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or diabetes definitively diagnosed by a community-level or higher medical institution. Patients with hypertension: systolic pressure <160 mmHg and diastolic pressure <100 mmHg on the day of immunization achieved by lifestyle adjustment and/or drug treatment; patients with diabetes: fasting glucose =13.9 mmol/L on the day of (or within 3 days before) immunization achieved by lifestyle adjustment and/or drug treatment. Exclusion Criteria: - Previously confirmed or asymptomatic COVID-19 patient. - Has been immunized with a SARS-CoV-2 vaccine. - Illiterate. - Known allergy to any ingredient (including excipient) of this product. - Received non-specific immunoglobulin injection within 1 month before enrollment. - Received a live attenuated vaccine within 1 month before immunization or other vaccine within 14 days before immunization. - Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria, angioedema, and dyspnea). - Has uncontrolled epilepsy and other progressive neurological disorders; history of Guillain-Barré syndrome. - Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and various acute diseases or acute onset of chronic diseases. - Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases. - Definitively diagnosed with thrombocytopenia or history of other coagulation disorders that may cause subcutaneous injection to be contraindicated. - Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic acidosis, etc.) of diabetes; or within 2 weeks after recovery from these complications. - Other physical conditions judged by the investigator that render the patient unsuitable for participation in the clinical study. |
Country | Name | City | State |
---|---|---|---|
China | Linli County Center for Disease Control and Prevention | Changde | Hunan |
China | Nan'an Center for Disease Control and Prevention | Quanzhou | Fujian |
China | Yong'an Center for Disease Control and Prevention | 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 |
Lead Sponsor | Collaborator |
---|---|
China National Biotec Group Company Limited | Beijing Institute of Biological Products Co Ltd., Fujian Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Hunan Center for Disease Control and Prevention |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroconversion rate | the rate of positive seroconversion against coronavirus | Up to 28 days after the second dose | |
Primary | Neutralizing antibody level | neutralizing antibody level against coronavirus | Up to 28 days after the second dose | |
Secondary | Adverse events following vaccination | analyse the incidence of adverse events following immunization, both solicited and unsolicited | up to 6 months |
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