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Post-marketing clinical study of novel coronavirus inactivated vaccine (Vero cells): evaluation of immunogenicity and safety in elderly people with chronic bronchitis and chronic obstructive pulmonary disease

Post-marketing clinical study of novel coronavirus inactivated vaccine (Vero cells): evaluation of immunogenicity and safety in elderly people with chronic bronchitis and chronic obstructive pulmonary disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054474
Enrollment
Unknown
Registered
2021-12-18
Start date
2021-08-30
Completion date
Unknown
Last updated
2022-11-20

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

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Sponsors

Hubei Provincial Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 60 and above with full capacity for civil conduct; 2. Chronic bronchitis research subjects: diagnosed with chronic bronchitis by first-level and above medical institutions; chronic obstructive pulmonary disease research subjects: diagnosed with chronic obstructive pulmonary disease by first-level and above medical institutions; 3. Axillary temperature < 37.3 degree C confirmed by clinical examination before entering this study; 4. Able and willing to complete the entire research plan during the entire study follow-up period; 5. The patients have the ability to understand the research procedures, sign the informed consent form voluntarily after informed consent, and be able to comply with the requirements of the clinical research protocol.

Exclusion criteria

Exclusion criteria: 1. The subject has previously been a confirmed case of the new crown or asymptomatic infection; 2. The subject has a history of new coronavirus vaccination; 3. Those who are known to be allergic to any ingredients (including excipients) contained in this product; 4. Injection of non-specific immunoglobulin within 1 month before enrollment; 5. Have been vaccinated with live attenuated vaccine within 1 month before vaccination, and have received other vaccines within 14 days before vaccination; 6. Those who have experienced severe allergic reactions to vaccines in the past (such as acute allergic reactions, urticaria, angioedema, dyspnea, etc.); 7. Those with uncontrolled epilepsy and other progressive neurological diseases, those with a history of Guillain-Barré syndrome; 8. Severe liver and kidney diseases, malignant tumors, various acute diseases or acute exacerbations of chronic diseases; 9. Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 10. A history of clearly diagnosed thrombocytopenia or other coagulation disorders, which may cause subcutaneous injections to be contraindicated; 11. During acute exacerbation of chronic bronchitis/chronic obstructive pulmonary disease; 12. Other subjects whose physical conditions are deemed unsuitable for inclusion in clinical research by the investigators.

Design outcomes

Primary

MeasureTime frame
Novel coronavirus antibody 4 times growth rate and antibody level (GMT, GMI);Incidence of adverse reactions/events;Incidence of serious adverse events (SAEs);

Countries

China

Contacts

Public ContactZhang Xianfeng

Hubei Provincial Center for Disease Control and Prevention

739425754@qq.com+86 17702795737

Outcome results

None listed

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