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A prospective, multicenter , clinical controlled study of COVID-19 vaccine for the elderly population

A prospective, multicenter , clinical controlled study of COVID-19 vaccine for the elderly population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049770
Enrollment
Unknown
Registered
2021-08-09
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-19

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

elderly group:covid-19 inactivated vaccine

Sponsors

the Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The new crown vaccine is planned; 2. Elderly subjects aged 60-80 and young and middle-aged subjects aged 18 to 59 years; 3. The subjects can and are willing to comply with the requirements of the clinical trial protocol, complete the 12-month study follow-up and sign the informed consent; 4. HBsAg, anti HCV, HIV and TPHA screening were negative; 5. The new crown RNA test was negative; 6. Axillary body temperature <=37.0 degree C.

Exclusion criteria

Exclusion criteria: 1. Women with positive urine pregnancy test, women who are pregnant, breastfeeding, or women who plan to become pregnant within 6 months; 2. Suffering from a serious chronic disease or the disease is in a progressive stage and cannot be controlled smoothly, such as diabetes, asthma, thyroid disease, etc. that cannot be controlled by drugs; 3. Suffering from thrombocytopenia, bleeding disorders or thrombotic disorders; 4. Suffering from more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by drugs, etc.; 5. Suffering from congenital or acquired angioedema/neurotic edema; 6. History or family history of convulsions, epilepsy, encephalopathy, other progressive neurological diseases and psychiatric diseases; 7. Suffering from lymphoma, leukemia and other systemic malignant tumors; 8. Suffering from autoimmune diseases; 9. Those with fainting needles; 10. Has received immunosuppressive therapy, antiallergic therapy, cytotoxic therapy, or inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis); 11. Received blood products within 4 months before receiving the experimental vaccine; 12. Received other research drugs within 1 month before receiving the experimental vaccine; 13. Receive other types of vaccines within 1 month before receiving the experimental vaccine; 14. Patients with acute exacerbation of chronic diseases or acute infectious diseases and fever.

Design outcomes

Primary

MeasureTime frame
2019 neutralizing antibody against New Coronavirus;

Countries

China

Contacts

Public ContactWang Fusheng

The Fifth Medical Center of Chinese People's Liberation Army General Hospital

fswang302@163.com+86 10 66933332

Outcome results

None listed

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