Safety observation of a COVID-19 vaccine in a large population

Multi-center Safety Observation of COVID19 Vaccine in a Large Population

This study is testing the safety of a new COVID-19 vaccine in a large group of 100,000 people, including those with health issues, to see how it affects their health after getting three doses.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (industry)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05890521 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety of a recombinant Novel Coronavirus protein vaccine in a large population, including both healthy individuals and those with specific health conditions. The trial will enroll 100,000 participants across multiple regions in China, with a focus on special populations such as those with obesity, chronic diseases, and other health issues. Participants will receive three doses of the vaccine, and their health will be monitored to assess any adverse effects. The study is designed to provide comprehensive safety data to inform future vaccination efforts.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals and those aged 18 and above with specific health conditions such as obesity or chronic diseases.

Not a fit: Patients with uncontrolled lymphoproliferative diseases or severe bleeding disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety profile of COVID-19 vaccines, particularly for vulnerable populations.

How similar studies have performed: Other studies have shown success in evaluating vaccine safety in diverse populations, making this approach both relevant and necessary.

Eligibility criteria

Inclusion Criteria:

1. Healthy people or special people aged 18 and above who meet the requirements of national new coronavirus vaccination (including but not limited to obesity (BMI ≥ 28kg/ m²). Chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc.); If the researcher determines that it is necessary, the special population shall provide relevant written diagnosis certificates, records or drug prescription certificates issued by doctors;
2. The subjects voluntarily participated in the study, signed the informed consent, understood and complied with the requirements of the clinical trial scheme, and were able to understand the research procedures.

Exclusion Criteria:

1. Patients with uncontrolled lymphoproliferative diseases, unresponsive aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled bleeding and coagulation diseases, etc;
2. People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
3. Patients suffering from acute disease, or acute attack of chronic disease, or uncontrolled severe chronic disease;
4. Previous history of severe allergy to any vaccine or any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, Henoch Schonlein purpura, thrombocytopenic purpura, dyspnea, angioneuroedema, etc;
5. The researchers believe that the subject has any disease or condition that may put the subject at unacceptable risk; The subjects could not meet the protocol requirements; Interference with the evaluation of vaccine response.

Where this trial is running

Changsha, Hunan

• Hunan Provincial Center for Disease Control and Prevention — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Lidong Gao

Conditions: COVID-19, Recombinant Novel Coronavirus Vaccine