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Evaluation of Immunization Effect of 2019-nCoV Inactivated Vaccine

Evaluation of Immunization Effect of 2019-nCoV Inactivated Vaccine

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045160
Enrollment
Unknown
Registered
2021-04-07
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-11-08

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

2019-nCoV Inactivated Vaccine group:Nil
non vaccinated group:Nil

Sponsors

Chongqing General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1.Healthy subjects aged 18-59 years; 2.Gender: male or non-pregnant or non-lactating female; 3.No history of major diseases, history of drug allergy and vaccination Allergy history; 4.No history of new coronary pneumonia or infection history, holding a health code "green code"; 5.Able to complete the two-month clinical research follow-up.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to any component of the vaccine, and those who have had severe allergic reactions to the vaccine in the past (such as anaphylactic shock, acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain); 2. Sufferers Acute disease, severe chronic disease, acute onset of chronic disease, and fever; 3. Pregnant women and lactating women, those who have a childbirth plan within 3 months of vaccination; 4. Have a history or family history of convulsions, epilepsy, encephalopathy or mental illness; suffer from uncontrolled epilepsy and other progressive neurological diseases Those with a history of Guillain-Barre syndrome; 5. Those who have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 6. Known or suspected Patients with severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors; 7. Those who use immunosuppressive drugs such as anti-tumor drugs; 8. Those who suffer from thrombocytopenia or bleeding disorders; 9. Clinicians Or the vaccination staff believes that they are not suitable for vaccination against the COVID-19.

Design outcomes

Primary

MeasureTime frame
2019-nCoV related antibodies;Cytokines;Serum peptide fingerprint;Proportion of T lymphocyte subsets;CD4/CD8 ratio;

Secondary

MeasureTime frame
Immune factor;Proteomics molecular profiling;Metabolomics molecular profiling;

Countries

China

Contacts

Public ContactLiao Pu

Chongqing General Hospital

liaopu@sina.com+86 23 63519127

Outcome results

None listed

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