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Post-Marketing clinical study of inactivated new coronavirus vaccine (Vero cells): Evaluation of immunogenicity and safety in people with hypertension and diabetes

Post-Marketing clinical study of inactivated new coronavirus vaccine (Vero cells): Evaluation of immunogenicity and safety in people with hypertension and diabetes

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054614
Enrollment
Unknown
Registered
2021-12-21
Start date
2021-07-16
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases caused by the new coronavirus

Interventions

Diabetes group:Inactivated new coronavirus vaccine (Vero cells)
Hypertension group:Inactivated new coronavirus vaccine (Vero cells)
Healthy control group:Inactivated new coronavirus vaccine (Vero cells)

Sponsors

Guizhou Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. People aged >= 60 years with full capacity for civil conduct; 2. Body temperature < 37.3? was confirmed by clinical examination before entering this study; 3. Able and willing to complete the entire research plan during the follow-up period; 4. I have the ability to understand the study procedure, sign the informed consent voluntarily with informed consent, and comply with the requirements of the clinical study protocol; 5. Inclusion criteria for patients with hypertension/diabetes: they must be diagnosed with hypertension and/or diabetes by a medical institution of grade I or above.

Exclusion criteria

Exclusion criteria: 1. Recipients have a history of COVID-19 infection or have tested positive for NUCLEIC acid; 2. Subjects have a history of COVID-19 vaccination; 3. Known to be allergic to any ingredients contained in the product (including excipients); 4. Injection of non-specific immunoglobulin within 1 month before enrollment; 5. Have received live attenuated vaccine within 1 month before inoculation and other vaccines within 14 days before inoculation; 6. Patients who have experienced severe allergic reactions to vaccines (such as acute allergic reactions, urticaria, angioneurotic edema, dyspnea, etc.); 7. Persons with uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome; 8. Serious respiratory diseases, serious liver and kidney diseases, malignant tumors, various acute diseases or acute episodes of chronic diseases; 9. Have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 10. A clearly diagnosed history of thrombocytopenia or other clotting disorders may contraindicate subcutaneous injection; 11. During the acute complications of diabetes (ketoacidosis, hyperosmolar state, lactic acidosis, etc.); Or the above complications have been cured less than 2 weeks; 12. Other patients whose physical conditions were deemed unsuitable for clinical study by the investigator.

Design outcomes

Primary

MeasureTime frame
Positive rate of neutralizing antibody and GMT level of neutralizing antibody in novel Coronavirus;Occurrence of adverse events within 3 months after full immunization;

Countries

China

Contacts

Public ContactZhang Ruizhi

Guizhou Center for Disease Control and Prevention

919987774@qq.com+86 13985441115

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026